Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307385
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-03-25
Brief Title:
Transcranial Direct Current Stimulation to Improve Hand Movement in Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modulation of Motor Learning After Stroke Using Principles of Metaplasticity
Status:
COMPLETED
Status Verified Date:
2008-03-27
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 hand movement in stroke patients can be improved by applying electrical stimulation to the side of the brain affected by the stroke It will compare the effects of similar brain stimulations in stroke patients and healthy volunteers
Healthy right-handed normal volunteers and stroke patients between 18 and 80 years of age may be eligible for this study Patients stroke must have occurred at least 3 months before entering the study and affect one side of the brain only Candidates are screened with a medical history brain MRI and evaluation of memory and attention span Pregnant women are excluded from the study
The study involves seven 2-day sessions over the course of about 8 weeks with each session separated by at least 1 week During each session participants practice a pattern of hand movements and their accuracy in performing the movements is evaluated before and after brain electrical stimulation The movements include a complex finger sequence a simple finger sequence a peg test placing wooden pegs in holes on a board a hand function test turning over cards picking up small objects with one hand and placing them in a can picking up small objects with a spoon and placing them in a can stacking checkers moving light cans and moving heavy cans and a box and block test picking up and moving blocks from one box to another
The first day of each 2-day session lasts about 5 hours and includes the following
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
Motor learning under tDCS tDCS is repeated while the subject performs different finger movements A new pattern of finger movements is taught each session
Surface electromyography Electrodes are filed 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
The second day of each session lasts about 2 hours and includes the TMS measurements and behavior measurements
Healthy right-handed normal volunteers and stroke patients between 18 and 80 years of age may be eligible for this study Patients stroke must have occurred at least 3 months before entering the study and affect one side of the brain only Candidates are screened with a medical history brain MRI and evaluation of memory and attention span Pregnant women are excluded from the study
The study involves seven 2-day sessions over the course of about 8 weeks with each session separated by at least 1 week During each session participants practice a pattern of hand movements and their accuracy in performing the movements is evaluated before and after brain electrical stimulation The movements include a complex finger sequence a simple finger sequence a peg test placing wooden pegs in holes on a board a hand function test turning over cards picking up small objects with one hand and placing them in a can picking up small objects with a spoon and placing them in a can stacking checkers moving light cans and moving heavy cans and a box and block test picking up and moving blocks from one box to another
The first day of each 2-day session lasts about 5 hours and includes the following
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
Motor learning under tDCS tDCS is repeated while the subject performs different finger movements A new pattern of finger movements is taught each session
Surface electromyography Electrodes are filed 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
The second day of each session lasts about 2 hours and includes the TMS measurements and behavior measurements
Detailed Description:
Objectives Recent advances in neuroscience may be helpful in designing more accurate neurorehabilitative strategies to decrease post-stroke disability First recovery is more extensive when the interhemispheric balance of activity favors the ipsilesional primary motor M1Ipsilesional and premotor PMIpsilesional cortices Second non-invasive transcranial direct current stimulation tDCS over M1Ipsilesional may help to transiently improve motor performance in stroke patients Third in healthy volunteers training combined with cortical stimulation of M1 which plays a critical role in motor learning leads to up-regulation of corticomotor excitability improved motor learning and use-dependent plasticity Since stroke patients have to re-learn how to control their paretic hand enhancing their learning capacity by adequate tuning of M1Ipsilesional with tDCS could promote plastic reorganization that supports functional improvement Finally another factor to be considered is that functional changes elicited by cortical stimulation depend on the previous activity state metaplasticity Therefore we hypothesize that implementing metaplastic changes will enhance motor learning gains induced by tDCS in chronic stroke patients to a larger extent than a control intervention in both stroke patients and healthy volunteers
Study Population 20 healthy subjects for safety issues and parameter optimization 31 patients with a single cortical or sub-cortical stroke and 31 matched healthy controls
Design To test our hypothesis we will precondition M1Ipsilesional with cathodal tDCS which transiently down-regulates activity in this site and then apply anodal tDCS to M1Ipsilesional during a motor sequence learning with the paretic hand After a familiarization session real and sham tDCS will be applied in 6 randomized sessions in a crossover design Learning will be evaluated one day after each tDCSsham session
The primary outcome measure will be the number of learned sequences correctly played on a keyboard in a 30-second period TMS will be used 1 to interfere with the activity of different cortical motor areas as a marker of their respective contribution to paretic hand control before and after the metaplasticity intervention and 2 to measure corticomotor excitability changes associated with the interventions This will provide descriptive information on the neural substrates underlying behavioral gains important for hypothesis-generation and power analysis in future investigations
Study Population 20 healthy subjects for safety issues and parameter optimization 31 patients with a single cortical or sub-cortical stroke and 31 matched healthy controls
Design To test our hypothesis we will precondition M1Ipsilesional with cathodal tDCS which transiently down-regulates activity in this site and then apply anodal tDCS to M1Ipsilesional during a motor sequence learning with the paretic hand After a familiarization session real and sham tDCS will be applied in 6 randomized sessions in a crossover design Learning will be evaluated one day after each tDCSsham session
The primary outcome measure will be the number of learned sequences correctly played on a keyboard in a 30-second period TMS will be used 1 to interfere with the activity of different cortical motor areas as a marker of their respective contribution to paretic hand control before and after the metaplasticity intervention and 2 to measure corticomotor excitability changes associated with the interventions This will provide descriptive information on the neural substrates underlying behavioral gains important for hypothesis-generation and power analysis in future investigations
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-0127 | None | None | None |