StrokeNCT00307385
Transcranial Direct Current Stimulation to Improve Hand Movement in Stroke Patients
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2006to 27 Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke Patients:
- age between 18-80 years
- first-ever, single stroke with thromboembolic non-hemorrhagic hemispheric lesions
- stroke more than 3 months ago
- stroke that affected one side of the brain (unilateral stroke)
- Patients with initially a severe motor paresis (below MRC grade 2), who subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks (i.e., perform relatively independent finger movements)
Show all 11Show fewer
- willing and able to give consent
- Healthy Volunteers:
- age between 18-80 years
- able to perform tasks required by the study
- willing and able to give consent
Who cannot join
- Stroke Patients:
- unable to perform the tasks of the study
- more than one stroke
- both sides of the brain affected or clear bilateral motor impairment
- stroke in the cerebellum or brainstem
- increased intracranial pressure as evaluated by clinical means
Show all 19Show fewer
- history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score (MMSE) of 23 or less), or degenerative brain processes such as Alzheimer's disease
- severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others), more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease
- receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants (for the TMS component)
- pregnant
- medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., dental braces, pacemakers, implanted medication pumps, cochlear devices, neural stimulators, metal in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)
- Healthy volunteers:
- unable to perform the tasks
- history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score (MMSE) of 23 or less), or degenerative brain processes such as Alzheimer's disease
- severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others), more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease
- problems with movement of the hands
- receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants (for the TMS component)
- pregnant
- medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., dental braces, pacemakers, implanted medication pumps, cochlear devices, neural stimulators, metal in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Modulation of Motor Learning After Stroke Using Principles of Metaplasticity
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.
Read more
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 subject's 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.
Read the 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 tDCS/sham 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.
- Conditions
- Stroke
- Keywords
- Motor Recovery, Transcranial Direct Current Stimulation (tDCS), Homeostatic Plasticity, Ipsilesional Primary Motor Cortex, Paretic Fingers Motor Sequence, Motor Cortex, Motor Function, Motor Learning, Premotor Cortex, Primary Motor Cortex, Stroke, Healthy Volunteer, HV
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study start23 Mar 2006
- Study completion27 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 82 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307385
- Sponsor's protocol ID
- 060127
- Other IDs
- 06-N-0127
- Status last verified
- 27 Mar 2008
- First submitted
- 25 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fridman EA, Hanakawa T, Chung M, Hummel F, Leiguarda RC, Cohen LG. Reorganization of the human ipsilesional premotor cortex after stroke. Brain. 2004 Apr;127(Pt 4):747-58. doi: 10.1093/brain/awh082. Epub 2004 Jan 28.
PubMed 14749291
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Motor Learning After Stroke Using Principles of Metaplasticity
- ClinicalTrials.gov ID
- NCT00307385
- Acronym / sponsor ID
- 060127
- Conditions
- Stroke
- Keywords
- Motor Recovery, Transcranial Direct Current Stimulation (tDCS), Homeostatic Plasticity, Ipsilesional Primary Motor Cortex, Paretic Fingers Motor Sequence, Motor Cortex, Motor Function, Motor Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 23 Mar 2006
- Study completion
- 27 Mar 2008
- First posted
- 27 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subject's 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 tDCS/sham 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 design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age between 18-80 years
- first-ever, single stroke with thromboembolic non-hemorrhagic hemispheric lesions
- stroke more than 3 months ago
- stroke that affected one side of the brain (unilateral stroke)
- Patients with initially a severe motor paresis (below MRC grade 2), who subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks (i.e., perform relatively independent finger movements)
Key exclusion criteria (19 listed)
- unable to perform the tasks of the study
- more than one stroke
- both sides of the brain affected or clear bilateral motor impairment
- stroke in the cerebellum or brainstem
- increased intracranial pressure as evaluated by clinical means
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 14749291Fridman EA, Hanakawa T, Chung M, Hummel F, Leiguarda RC, Cohen LG. Reorganization of the human ipsilesional premotor cortex after stroke. Brain. 2004 Apr;127(Pt 4):747-58. doi: 10.1093/brain/awh082. Epub 2004 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00307385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.