Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314769
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2006-04-13
Brief Title:
Long-Term Improvement in Motor Learning by Transcranial Direct Current Stimulation
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Improvement in Training Effects by Transcranial DC Stimulation
Status:
COMPLETED
Status Verified Date:
2013-12-16
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:
None
Brief Summary:
This study will examine whether continuous use of transcranial direct current stimulation tDCS in combination with motor training can lead to long-term improvement in movement performance beyond what can be achieved with motor training alone
Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be eligible for this study Each candidate is screened with a medical history clinical and neurological examination questionnaires to evaluate memory attention and handedness and a brain MRI if one has not been done by NINDS within 12 months of entering the study Pregnant women may not participate
The study involves 10 sessions in addition to the screening visit over 3 months Sessions 1-5 are completed over 5 consecutive days Sessions 6-10 are divided over the remaining time Participants are randomly assigned to one of three groups 1 tDCS during motor training 2 tDCS after training or 3 training with sham tDCS During these sessions participants perform a pinch force task squeezing a small device between the thumb and forefinger and visuomotor tasks using a device to move the cursor on a computer screen to various targets and holding the cursor in place for 1 second
During the motor training and performance sessions participants have the following procedures
TMS measurements A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
tDCS Small wet sponge electrodes are applied to the head - one above the eye and the other on the back of the head A small electrical current is passed between them The subject may feel an itching or tingling sensation under the electrodes or see light flashes Some sessions are done with sham tDCS
Surface electromyography Electrodes are filled with a conductive gel and taped to the skin over one small hand muscle to measure the electrical activity of muscles
Behavioral measurements Evaluation of learned movement tasks
Questionnaires to evaluate the subjects attention fatigue and mood before and after testing
Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be eligible for this study Each candidate is screened with a medical history clinical and neurological examination questionnaires to evaluate memory attention and handedness and a brain MRI if one has not been done by NINDS within 12 months of entering the study Pregnant women may not participate
The study involves 10 sessions in addition to the screening visit over 3 months Sessions 1-5 are completed over 5 consecutive days Sessions 6-10 are divided over the remaining time Participants are randomly assigned to one of three groups 1 tDCS during motor training 2 tDCS after training or 3 training with sham tDCS During these sessions participants perform a pinch force task squeezing a small device between the thumb and forefinger and visuomotor tasks using a device to move the cursor on a computer screen to various targets and holding the cursor in place for 1 second
During the motor training and performance sessions participants have the following procedures
TMS measurements A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the subject may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the subject may hear a click and feel a pulling sensation on the skin under the coil
tDCS Small wet sponge electrodes are applied to the head - one above the eye and the other on the back of the head A small electrical current is passed between them The subject may feel an itching or tingling sensation under the electrodes or see light flashes Some sessions are done with sham tDCS
Surface electromyography Electrodes are filled with a conductive gel and taped to the skin over one small hand muscle to measure the electrical activity of muscles
Behavioral measurements Evaluation of learned movement tasks
Questionnaires to evaluate the subjects attention fatigue and mood before and after testing
Detailed Description:
OBJECTIVES
Motor practice and use over one session leads to use-dependent plasticity When practice is repeated over multiple sessions motor performance continues improving until a plateau in performance the so-called ceiling effect is reached This issue is particularly important in neurorehabilitative treatments in which patients usually reach a ceiling effect without further improvement Thus it would be desirable to modify ceiling effects in motor rehabilitation The purpose of this protocol is to determine if repeated applications of TDCS a form of non-invasive cortical stimulation known to transiently improve performance in association with training could elicit additional improvements in motor performance beyond the ceiling effect identified during performance of a visuomotor training task
We will test the hypothesis that anodal TDCS applied over M1 in temporal relation with motor training will lead to more prominent long-term learning of a visuomotor task relative to sham stimulation which would document the ceiling effect in healthy individuals and chronic stroke patients and traumatic brain injury TB1 patients
STUDY POPULATION
We plan to study 177 healthy volunteers part 1 and 60 chronic stroke patients part 2 and 50 TB1 patients with 50 additional healthy volunteers part 3 Therefore an overall enrollment of 337 participants is planned
DESIGN
The study will follow a parallel design Healthy volunteers part 1 and stroke patients part 2will be randomly allocated to one of three groups Each group will receive anodal TDCS or sham in a fixed time frame related to motor training during or immediately after motor training TB1 patients and healthy volunteers part 3 will be randomly allocated to one of two groups Each group will receive either sham or anodal tDCS during training
Healthy volunteers and stroke patients will participate in 10 sessions First they will train a visuomotor task VMT on 5 consecutive days while receiving sham stimulation group 3 or TDCS during group 1 or immediately after group 2 the training Performance of the VMT will be re-evaluated at 30 60 and 90 days after the first training session
Traumatic brain injury TB1 patients and a group of healthy volunteers part 3 will participate in 6 sessions First they will train a visumomotor task VMT on 3 consecutive days while receiving anodal tDCS or sham stimulation during the training Performance of the VMT will be re-evaluated at 30 60 and 90 days after the first training session
OUTCOME MEASURES
Primary outcome measure will be the percentage change from baseline to day 8 in healthy volunteers and stroke patients and from baseline to day 3 in traumatic brain injury in the total time necessary to complete 15 correct trials of the visuomotor task
Secondary outcome will be accuracy no of errors and timing speed variability of force adaptation in the visuomotor task Celnik own data and pinch force at all other time points including day 5 as a measure of learning over the training period and 3 months as a measure for long-term retention In the patient group the Jebsen Taylor Test will be used to assess gross motor function To better understand the mechanisms underlying the proposed behavioral gains we will use single- and paired pulse transcranial magnetic stimulation TMS to identify corticomotor excitability changes Furthermore the volunteers will answer several questionnaires to evaluate fatigue and mood PANAS and perform short neuropsychological control task to control for changes in attention and memory function
Motor practice and use over one session leads to use-dependent plasticity When practice is repeated over multiple sessions motor performance continues improving until a plateau in performance the so-called ceiling effect is reached This issue is particularly important in neurorehabilitative treatments in which patients usually reach a ceiling effect without further improvement Thus it would be desirable to modify ceiling effects in motor rehabilitation The purpose of this protocol is to determine if repeated applications of TDCS a form of non-invasive cortical stimulation known to transiently improve performance in association with training could elicit additional improvements in motor performance beyond the ceiling effect identified during performance of a visuomotor training task
We will test the hypothesis that anodal TDCS applied over M1 in temporal relation with motor training will lead to more prominent long-term learning of a visuomotor task relative to sham stimulation which would document the ceiling effect in healthy individuals and chronic stroke patients and traumatic brain injury TB1 patients
STUDY POPULATION
We plan to study 177 healthy volunteers part 1 and 60 chronic stroke patients part 2 and 50 TB1 patients with 50 additional healthy volunteers part 3 Therefore an overall enrollment of 337 participants is planned
DESIGN
The study will follow a parallel design Healthy volunteers part 1 and stroke patients part 2will be randomly allocated to one of three groups Each group will receive anodal TDCS or sham in a fixed time frame related to motor training during or immediately after motor training TB1 patients and healthy volunteers part 3 will be randomly allocated to one of two groups Each group will receive either sham or anodal tDCS during training
Healthy volunteers and stroke patients will participate in 10 sessions First they will train a visuomotor task VMT on 5 consecutive days while receiving sham stimulation group 3 or TDCS during group 1 or immediately after group 2 the training Performance of the VMT will be re-evaluated at 30 60 and 90 days after the first training session
Traumatic brain injury TB1 patients and a group of healthy volunteers part 3 will participate in 6 sessions First they will train a visumomotor task VMT on 3 consecutive days while receiving anodal tDCS or sham stimulation during the training Performance of the VMT will be re-evaluated at 30 60 and 90 days after the first training session
OUTCOME MEASURES
Primary outcome measure will be the percentage change from baseline to day 8 in healthy volunteers and stroke patients and from baseline to day 3 in traumatic brain injury in the total time necessary to complete 15 correct trials of the visuomotor task
Secondary outcome will be accuracy no of errors and timing speed variability of force adaptation in the visuomotor task Celnik own data and pinch force at all other time points including day 5 as a measure of learning over the training period and 3 months as a measure for long-term retention In the patient group the Jebsen Taylor Test will be used to assess gross motor function To better understand the mechanisms underlying the proposed behavioral gains we will use single- and paired pulse transcranial magnetic stimulation TMS to identify corticomotor excitability changes Furthermore the volunteers will answer several questionnaires to evaluate fatigue and mood PANAS and perform short neuropsychological control task to control for changes in attention and memory function
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-N-0138 | None | None | None |