Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613282
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Randomized Single-blind Trial of LI-TMS and AVS for Stoke Recovery in Healthy Participants Phase 1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Single-blind Study of LI-TMS and AVS for Stroke Recovery in Healthy Participants with the Evaluation of the Effect on the Subject Using EEG and the Following Testing
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation LI-TMS and audio-visual stimulation AVS and newly offered interventional protocols in healthy participants for further research on stroke rehabilitation and therapeutic effects
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation
The main questions it aims to answer are
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency WE of the participant Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator WU of the participant Does intervention with LI-TMS and AVS influence the parameter Psychological Stability PS of the participant Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy Tv of the participant Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions
Participants will
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday
Attend the clinic 3 times during the trial and undergo testing and screening The first clinic visit is before the intervention course The second clinic visit will be the day immediately following the end of the two-week intervention course The third visit will be two weeks after the second visit
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation
The main questions it aims to answer are
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency WE of the participant Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator WU of the participant Does intervention with LI-TMS and AVS influence the parameter Psychological Stability PS of the participant Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy Tv of the participant Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions
Participants will
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday
Attend the clinic 3 times during the trial and undergo testing and screening The first clinic visit is before the intervention course The second clinic visit will be the day immediately following the end of the two-week intervention course The third visit will be two weeks after the second visit
Detailed Description:
Stroke is a leading cause of disability worldwide significantly impacting individuals quality of life and their ability to perform daily activities Rehabilitation is critical for stroke survivors as it aims to restore function improve mobility and enhance overall well-being
Auditory-visual stimulation AVS is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery This approach is based on the principles of neuroplasticity which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke
Transcranial Magnetic Stimulation TMS is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp which induces electrical currents in specific brain regions This method is believed to facilitate neuroplasticity the brains ability to reorganize itself by forming new neural connections
LI-TMS is a variant of TMS that uses lower intensity magnetic fields This technique is designed to minimize discomfort while still promoting neuroplasticity Key aspects of LI-TMS include
1 Safety and Tolerability LI-TMS is generally well-tolerated making it suitable for patients who may be sensitive to higher-intensity stimulation
2 Potential for Long-Term Effects Studies suggest that LI-TMS may lead to sustained improvements in motor function and cognitive abilities even after treatment has ended
3 Combination with Other Therapies LI-TMS can be effectively combined with traditional rehabilitation methods enhancing overall therapeutic outcomes
This study aims to test the proposed interventional protocols using a prototype device for low-intensity repetitive transcranial magnetic stimulation LI-TMS and audio-visual stimulation AVS on healthy participants
Participants in the experimental group are screened and tested upon their first visit to the hospital Afterward intervention courses are run five days a week for two weeks Activities take place on Monday Tuesday Wednesday Thursday and Friday while Saturday and Sunday are free Interventions of each protocol are applied for two days in routine At the end of the intervention course participants are screened and tested again at the hospital and after two weeks
The following is how the Interventional procedure goes first the device will be plugged in and tested then in 5 minutes the subject sits in a comfortable chair further a disposable hair cap is put on hisher head a textile helmet with coil emitters is put on top of the disposable hair cap then glasses with Red Green Blue Light-emitting diodes and stereo headphones The Interventional protocol was selected in prototype software In conformance with the selected Interventional protocol the characteristics of the exposure signal were then set up The button on the prototypes touch screen was pressed next The intervention procedure was stopped when the time on the timer on the touch screen of the prototype expired When the exposure procedure was over the prototype was switched off and all its exposure units were taken off of the test subject in reverse order
The study will involve two groups an experimental group and a control group The experimental group consisting of 30 healthy participants will receive a course of interventions over two weeks of days The comparison will be made with a control group consisting of 10 healthy participants who will receive no intervention only screening and testing
Interventions Experimental Day 1 and Day 2
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus A stimulation frequency of 6 Hz is applied to all emitters The signal waveform to be used has a sinusoidal shape and bipolar type
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 446 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 7 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 3 and Day 4
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus The frequencies of the stimulation signal are varied as follows at the initial stage the signal frequency is 4 Hz is applied to all emitters and lasts for 6 minutes then the frequency increases to 5 Hz for the next 6 minutes then to 6 Hz for the next 6 minutes then to 7 Hz for the next 6 minutes and at the final stage the signal frequency is 8 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and bipolar type
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 5
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus Frequencies of the stimulation signal are varied as follows in the initial stage the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz and lasts for 6 minutes In the next stage the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz and lasts for 6 minutes Next the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 6 Hz and lasts for 6 minutes Then the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 7 Hz and lasts for 6 minutes In the final step the signal carrier frequency and modulating frequency are equal to 8 Hz resulting in the signal being a regular sinusoid with a frequency of 8 Hz and lasting 6 minutes Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 6 Day of no interventions Experimental Day 7 Day of no interventions Experimental Day 8
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus Frequencies of the stimulation signal are varied as follows in the initial stage the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz and lasts for 6 minutes In the next stage the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz and lasts for 6 minutes Next the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 6 Hz and lasts for 6 minutes Then the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 7 Hz and lasts for 6 minutes In the final step the signal carrier frequency and modulating frequency are equal to 8 Hz resulting in the signal being a regular sinusoid with a frequency of 8 Hz and lasting 6 minutes Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 9 and Day 10
1 For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area The stimulation frequencies were as follows the carrier signal frequency was 13 Hz and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The shape of the carrier signal was a sine wave and the shape of the modulating signal was a cosine wave The signal type is bipolar Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 440 n Hz where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 1 n Hz where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 11 and Day 12
1 For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area The stimulation frequencies were as follows the carrier signal frequency was 25 Hz and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The shape of the carrier signal was a sine wave and the shape of the modulating signal was a cosine wave The signal type is bipolar Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 440 n Hz where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 1 n Hz where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 13 Day of no interventions Experimental Day 14 Day of no interventions
Control Day 1 - Day 14 The control group does not receive any intervention for 14 days
Participants in the experimental group and control group are screened and tested on the first day and on day fourteen and on day 28th of the study
Auditory-visual stimulation AVS is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery This approach is based on the principles of neuroplasticity which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke
Transcranial Magnetic Stimulation TMS is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp which induces electrical currents in specific brain regions This method is believed to facilitate neuroplasticity the brains ability to reorganize itself by forming new neural connections
LI-TMS is a variant of TMS that uses lower intensity magnetic fields This technique is designed to minimize discomfort while still promoting neuroplasticity Key aspects of LI-TMS include
1 Safety and Tolerability LI-TMS is generally well-tolerated making it suitable for patients who may be sensitive to higher-intensity stimulation
2 Potential for Long-Term Effects Studies suggest that LI-TMS may lead to sustained improvements in motor function and cognitive abilities even after treatment has ended
3 Combination with Other Therapies LI-TMS can be effectively combined with traditional rehabilitation methods enhancing overall therapeutic outcomes
This study aims to test the proposed interventional protocols using a prototype device for low-intensity repetitive transcranial magnetic stimulation LI-TMS and audio-visual stimulation AVS on healthy participants
Participants in the experimental group are screened and tested upon their first visit to the hospital Afterward intervention courses are run five days a week for two weeks Activities take place on Monday Tuesday Wednesday Thursday and Friday while Saturday and Sunday are free Interventions of each protocol are applied for two days in routine At the end of the intervention course participants are screened and tested again at the hospital and after two weeks
The following is how the Interventional procedure goes first the device will be plugged in and tested then in 5 minutes the subject sits in a comfortable chair further a disposable hair cap is put on hisher head a textile helmet with coil emitters is put on top of the disposable hair cap then glasses with Red Green Blue Light-emitting diodes and stereo headphones The Interventional protocol was selected in prototype software In conformance with the selected Interventional protocol the characteristics of the exposure signal were then set up The button on the prototypes touch screen was pressed next The intervention procedure was stopped when the time on the timer on the touch screen of the prototype expired When the exposure procedure was over the prototype was switched off and all its exposure units were taken off of the test subject in reverse order
The study will involve two groups an experimental group and a control group The experimental group consisting of 30 healthy participants will receive a course of interventions over two weeks of days The comparison will be made with a control group consisting of 10 healthy participants who will receive no intervention only screening and testing
Interventions Experimental Day 1 and Day 2
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus A stimulation frequency of 6 Hz is applied to all emitters The signal waveform to be used has a sinusoidal shape and bipolar type
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 446 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 7 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 3 and Day 4
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus The frequencies of the stimulation signal are varied as follows at the initial stage the signal frequency is 4 Hz is applied to all emitters and lasts for 6 minutes then the frequency increases to 5 Hz for the next 6 minutes then to 6 Hz for the next 6 minutes then to 7 Hz for the next 6 minutes and at the final stage the signal frequency is 8 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and bipolar type
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 5
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus Frequencies of the stimulation signal are varied as follows in the initial stage the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz and lasts for 6 minutes In the next stage the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz and lasts for 6 minutes Next the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 6 Hz and lasts for 6 minutes Then the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 7 Hz and lasts for 6 minutes In the final step the signal carrier frequency and modulating frequency are equal to 8 Hz resulting in the signal being a regular sinusoid with a frequency of 8 Hz and lasting 6 minutes Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 6 Day of no interventions Experimental Day 7 Day of no interventions Experimental Day 8
1 For low-intensity transcranial magnetic stimulation six radiating coils are placed in the temporal region above the hippocampus Frequencies of the stimulation signal are varied as follows in the initial stage the carrier frequency of the signal is 8 Hz and the modulating frequency is 4 Hz and lasts for 6 minutes In the next stage the carrier frequency of the signal stays 8 Hz and the modulating frequency increases to 5 Hz and lasts for 6 minutes Next the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 6 Hz and lasts for 6 minutes Then the carrier frequency of the signal stays 8 Hz and the modulating frequency is increased to 7 Hz and lasts for 6 minutes In the final step the signal carrier frequency and modulating frequency are equal to 8 Hz resulting in the signal being a regular sinusoid with a frequency of 8 Hz and lasting 6 minutes Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear in the initial stage is 440 Hz and for the right ear is 444 Hz and lasts for 6 minutes In the next stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 445 Hz and lasts for 6 minutes Next the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 446 Hz and lasts 6 minutes Then the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 447 Hz and lasts for 6 minutes In the final stage the frequency for the left ear stays 440 Hz and the frequency for the right ear increases to 448 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye in the initial stage is 1 Hz and for the right eye is 5 Hz and lasts for 6 minutes In the next stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 6 Hz and lasts for 6 minutes Next the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 7 Hz and lasts for 6 minutes Then the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 8 Hz and lasts for 6 minutes In the final stage the frequency for the left eye stays 1 Hz and the frequency for the right eye increases to 9 Hz and lasts for 6 minutes The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to red in the initial stage and the right eye is exposed to green and lasts for 6 minutes In the next stage the left eye is exposed to the colour blue and the right eye is exposed to the colour violet and lasts for 6 minutes Next the left eye is exposed to the colour green and the right eye is exposed to the colour blue and lasts for 6 minutes Then the left eye is exposed to the colour violet and the right eye is exposed to the colour green and lasts for 6 minutes In the final stage the left eye is exposed to the colour green and the right eye to the colour red and lasts for 6 minutes
5 The total time duration of the procedure is 30 minutes Experimental Day 9 and Day 10
1 For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area The stimulation frequencies were as follows the carrier signal frequency was 13 Hz and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The shape of the carrier signal was a sine wave and the shape of the modulating signal was a cosine wave The signal type is bipolar Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 440 n Hz where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 1 n Hz where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 9 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 11 and Day 12
1 For low-intensity transcranial magnetic stimulation involved all 32 magnetic emitters located over the entire scalp area The stimulation frequencies were as follows the carrier signal frequency was 25 Hz and the modulating signal frequency was determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The shape of the carrier signal was a sine wave and the shape of the modulating signal was a cosine wave The signal type is bipolar Carrier signal waveform - sine wave modulating signal waveform - cosine wave The signal type is bipolar
2 For auditory stimulation a binaural beats technique is used where the frequency for the left ear is 440 Hz and for the right ear is 440 n Hz where n is a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
3 For visual stimulation the technique of different frequencies of the signals applied to the eyes is used where the frequency for the left eye is 1 Hz and for the right eye is 1 n Hz where n represents a frequency value determined by the operator based on the participants previously measured electroencephalogram eg 14 Hz The signal waveform to be used has a sinusoidal shape and unipolar type
4 For colour stimulation the left eye is exposed to blue for 6 minutes in the initial stage and green for 6 minutes in the final stage The right eye is exposed to the colour green for 6 minutes in the initial stage and blue for 6 minutes in the final stage as well
5 The total time duration of the procedure is 12 minutes Experimental Day 13 Day of no interventions Experimental Day 14 Day of no interventions
Control Day 1 - Day 14 The control group does not receive any intervention for 14 days
Participants in the experimental group and control group are screened and tested on the first day and on day fourteen and on day 28th of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None