Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947318
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-06-12
Brief Title:
Effect of tACS on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic Stroke Patients
Sponsor:
Universidad Metropolitana de Ciencias de la Educacion
Organization:
Universidad Metropolitana de Ciencias de la Educacion
Study Overview
Official Title:
Effect of Transcranial Alternating Current Stimulation on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic-stage Stroke Patients
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tACS
Brief Summary:
This project seeks to evaluate the effect of transcranial alternating current stimulation tACS on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14-sessions 5-week rehabilitation program for adult patients with diagnosis of stroke at chronic stage Specifically the stimulation on Gamma ranges because the evidence available so far allows us to propose that the tACS in the Gamma range around 70 Hz facilitates motor execution
For this purpose the experimental approach involves active 70 Hz in Gamma rhythm and 7 Hz Theta rhythm and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range which enhances the upper limb motor recovery associated with a training program
Using specific motor control parameters clinical scales and electroencephalography the immediate and long-term 3 months after finished the training behavioral and neurophysiological effect of this new neurostimulation paradigm tACS plus training for motor rehabilitation of stroke will be established
For this purpose the experimental approach involves active 70 Hz in Gamma rhythm and 7 Hz Theta rhythm and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range which enhances the upper limb motor recovery associated with a training program
Using specific motor control parameters clinical scales and electroencephalography the immediate and long-term 3 months after finished the training behavioral and neurophysiological effect of this new neurostimulation paradigm tACS plus training for motor rehabilitation of stroke will be established
Detailed Description:
This project seeks to evaluate the effect of transcranial alternating current stimulation tACS on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14 sessions 5 week rehabilitation program for adult patients with diagnosis of stroke at chronic stage Specifically the stimulation on Gamma ranges because the evidence available so far allows us to propose that the tACS in the Gamma range around 70 Hz facilitates motor execution For this purpose the experimental approach involves active 70 Hz in Gamma rhythm and 7 Hz Theta rhythm and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range which enhances the upper limb motor recovery associated with a training program
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients
The specifics objectives to accomplish this are 1 Implement a system for simultaneous measurement of motor activity and EEG under tACS considering possible postural alterations in stroke patients 2 Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program Training will include analytical and functional tasks to optimize the performance in function and activity ICF level tACS will be applied only during analytical task 3 Analyze the changes in motor performance and neuronal synchrony for the experimental groups
Using specific motor control parameters kinetic and kinematic control clinical scales and electroencephalography the immediate and long-term 3 months after finished the training behavioral and neurophysiological effect of this new neurostimulation paradigm tACS plus training for motor rehabilitation of stroke will be established
By means of analysis of variance clustering comparisons and linear regressions it will be established the effect of tACS on neuronal synchrony and the parallel motor activity as well as their underlying relationship
We will use the REDCap platform to register all the clinical data given by the medical record and clinical assessments
The recruitment will be made at the Clinical Center of Metropolitan University of Educational Sciences and in the Primary Care Centers that are near to the University The sample size is 45 chronic stage stroke survivors The sample size calculation used the data available in the study for the difference in Fugl-Meyer score between the bihemispheric and sham transcranial Direct Current Stimulation groups after the intervention in the study of Alisar et al 2020 considering an effect size of 14 a p-value of 005 and a power 1- beta of 09 which yielded a sample size of 12 subjects per group Now also considering an attrition percentage of 20 and an equivalence in the size of the 3 study groups the final sample size is 15 people per group 45 people in total
To answer the study hypothesis two variables will be examined as primary results
1 Behavioral level it will be the score on the Fugl-Meyer scale upper extremity section This scale has been widely used in the field of neurorehabilitation to assess motor impairments ICF function level
2 Neurophysiological level the primary outcome will be the change in spectral power in the Beta band 13-30Hz associated with motor performance in kinetic and kinematic tasks Signal processing will follow a cluster approach using the Fieldtrip toolbox in Matlab software R2016B
Both variables will be subjected to a two-factor analysis of variance experimental group factor 3 levels tACS-70Hz 7Hz and simulated and time factor 4 levels referred to the measurement times Depending on the result it will apply a post-hoc test bonferroni to study differences between levels and interactions The association between the variables will be inspected through regression models The level of significance will have a p-value of 005 The statistical analysis will be implemented in the R language and the Rstudio software Complementary to the primary results and in order to broaden the description of the study phenomenon the scores of the clinical scales already described will be analyzed as well as kinetic absolute force speed of force change and kinematic variables direction error maximum speed of the analytical and combined tasks In addition the long-scale synchrony will be described by means of connectivity variables between the electrodes already identified phase locking value and weighted phase lag index
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range which enhances the upper limb motor recovery associated with a training program
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients
The specifics objectives to accomplish this are 1 Implement a system for simultaneous measurement of motor activity and EEG under tACS considering possible postural alterations in stroke patients 2 Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program Training will include analytical and functional tasks to optimize the performance in function and activity ICF level tACS will be applied only during analytical task 3 Analyze the changes in motor performance and neuronal synchrony for the experimental groups
Using specific motor control parameters kinetic and kinematic control clinical scales and electroencephalography the immediate and long-term 3 months after finished the training behavioral and neurophysiological effect of this new neurostimulation paradigm tACS plus training for motor rehabilitation of stroke will be established
By means of analysis of variance clustering comparisons and linear regressions it will be established the effect of tACS on neuronal synchrony and the parallel motor activity as well as their underlying relationship
We will use the REDCap platform to register all the clinical data given by the medical record and clinical assessments
The recruitment will be made at the Clinical Center of Metropolitan University of Educational Sciences and in the Primary Care Centers that are near to the University The sample size is 45 chronic stage stroke survivors The sample size calculation used the data available in the study for the difference in Fugl-Meyer score between the bihemispheric and sham transcranial Direct Current Stimulation groups after the intervention in the study of Alisar et al 2020 considering an effect size of 14 a p-value of 005 and a power 1- beta of 09 which yielded a sample size of 12 subjects per group Now also considering an attrition percentage of 20 and an equivalence in the size of the 3 study groups the final sample size is 15 people per group 45 people in total
To answer the study hypothesis two variables will be examined as primary results
1 Behavioral level it will be the score on the Fugl-Meyer scale upper extremity section This scale has been widely used in the field of neurorehabilitation to assess motor impairments ICF function level
2 Neurophysiological level the primary outcome will be the change in spectral power in the Beta band 13-30Hz associated with motor performance in kinetic and kinematic tasks Signal processing will follow a cluster approach using the Fieldtrip toolbox in Matlab software R2016B
Both variables will be subjected to a two-factor analysis of variance experimental group factor 3 levels tACS-70Hz 7Hz and simulated and time factor 4 levels referred to the measurement times Depending on the result it will apply a post-hoc test bonferroni to study differences between levels and interactions The association between the variables will be inspected through regression models The level of significance will have a p-value of 005 The statistical analysis will be implemented in the R language and the Rstudio software Complementary to the primary results and in order to broaden the description of the study phenomenon the scores of the clinical scales already described will be analyzed as well as kinetic absolute force speed of force change and kinematic variables direction error maximum speed of the analytical and combined tasks In addition the long-scale synchrony will be described by means of connectivity variables between the electrodes already identified phase locking value and weighted phase lag index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None