Cerebrovascular AccidentNCT00067197
Improving Motor Learning in Stroke Patients
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
No universally successful therapy exists that promotes recovery of motor function after a stroke, the main cause of long-term disability among adults. The purpose of this study is to develop strategies to improve recovery of lost motor function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2003to 17 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 3 months after the stroke.
- We will choose Patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. Assessment of the initial functional state will be taken either from patient report or medical records.
- As the control group, we will include age- and gender matched Normal Volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).
Who cannot join
- Patients with more than one stroke in the medical cerebral artery territory.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients or Normal Volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
- Patients or Normal Volunteers with 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 of 23 or less).
- Patients or Normal Volunteers with history of 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).
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- Patients or Normal Volunteers with increased intracranial pressure as evaluated by clinical means.
- Patients or Normal Volunteers with unstable cardiac arrhythmia.
- Patients or Normal Volunteers with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
- Patients and Normal Volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
- Patients or Normal Volunteers which are or which have been professional piano players.
- Pregnancy.
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 in Chronic Stroke Patients by Transcranial DC Stimulation
No universally successful therapy exists that promotes recovery of motor function after a stroke, the main cause of long-term disability among adults.
The purpose of this study is to develop strategies to improve recovery of lost motor function. It will combine motor skills training with a brain-stimulating technique called transcranial direct current stimulation (tDCS).
Read more
Healthy adult volunteers and adult stroke patients will be enrolled in this study. Participants will come to NIH for a clinical and neurological exam, and, if necessary, an MRI [magnetic resonance imaging] examination. Participants will return for 4 sessions; each lasting approximately 3 hours. The first will be a practice session during which participants will become familiar with the motor skills required of them in this study, such as performing finger movements on a keyboard, pinching, tapping, making wrist movements, and lifting small items. In sessions 2 and 3, participants will perform the motor skills they practiced in session 1 while receiving tDCS. During session 4, they will receive tDCS only, with no performance of motor skills.
During tDCS, investigators will place electrodes with a gel on participants' heads and pass the tDCS current between these two electrodes. tDCS is a painless procedure.
Participants will receive up to $420 in compensation for their involvement in this study.
...
Read the detailed description
There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strategies to accelerate motor learning in this patient group. Previous studies in healthy volunteers demonstrated that cortical stimulation in association with training leads to improvements of motor learning and use-dependent plasticity. The purpose of this protocol is to apply a painless stimulation technique to the motor cortex of the affected hemisphere of patients with subcortical stroke (transcranial DC stimulation, tDCS) to test the hypothesis that tDCS of the motor cortex of the affected hemisphere in association with motor training will improve motor learning of a finger sequence in the paretic hand.
Furthermore, recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere. This abnormality might adversely influence motor recovery. Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere to test the hypothesis that reduction of the inhibitory influence of the unaffected hemisphere over the affected in association with motor training will improve motor learning.
This technique has been so far applied in several hundred subjects worldwide in the absence of undesirable side effects reported to date.
We plan to study patients with chronic strokes and healthy age- and gender matched normal volunteers. Primary outcome measure will be the number of correct keyboard piano sequences played in a specific time-period (30 seconds). Secondary outcome measures are speed of tapping with only one finger; simple reaction times; pinch force; and a functional measure of activities of daily life (ADL): Jebsen-Tailor-Test. To better understand the mechanisms underlying the proposed behavioral gains, we will use TMS to identify changes in corticomotor excitability.
- Conditions
- Cerebrovascular Accident
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Cortical Reorganization, Rehabilitation, Motor Learning, Activity of Daily Living (ADL), 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 posted13 Aug 2003 (estimated)
- Study start11 Aug 2003
- Study completion17 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- 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
- 76 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067197
- Sponsor's protocol ID
- 030267
- Other IDs
- 03-N-0267
- Status last verified
- 17 Jul 2008
- First submitted
- 12 Aug 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
PubMed 11723286Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Karni A, Meyer G, Jezzard P, Adams MM, Turner R, Ungerleider LG. Functional MRI evidence for adult motor cortex plasticity during motor skill learning. Nature. 1995 Sep 14;377(6545):155-8. doi: 10.1038/377155a0.
PubMed 7675082
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 in Chronic Stroke Patients by Transcranial DC Stimulation
- ClinicalTrials.gov ID
- NCT00067197
- Acronym / sponsor ID
- 030267
- Conditions
- Cerebrovascular Accident
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Cortical Reorganization, Rehabilitation, Motor Learning, Activity of Daily Living (ADL), Stroke, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Aug 2003
- Study completion
- 17 Jul 2008
- First posted
- 13 Aug 2003 (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.
No universally successful therapy exists that promotes recovery of motor function after a stroke, the main cause of long-term disability among adults.
The purpose of this study is to develop strategies to improve recovery of lost motor function. It will combine motor skills training with a brain-stimulating technique called transcranial direct current stimulation (tDCS).
Healthy adult volunteers and adult stroke patients will be enrolled in this study. Participants will come to NIH for a clinical and neurological exam, and, if necessary, an MRI [magnetic resonance imaging] examination. Participants will return for 4 sessions; each lasting approximately 3 hours. The first will be a practice session during which participants will become familiar with the motor skills required of them in this study, such as performing finger movements on a keyboard, pinching, tapping, making wrist movements, and lifting small items. In sessions 2 and 3, participants will perform the motor skills they practiced in session 1 while receiving tDCS. During session 4, they will receive tDCS only, with no performance of motor skills.
During tDCS, investigators will place electrodes with a gel on participants' heads and pass the tDCS current between these two electrodes. tDCS is a painless procedure.
Participants will receive up to $420 in compensation for their involvement in this study.
...
Detailed description
There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strategies to accelerate motor learning in this patient group. Previous studies in healthy volunteers demonstrated that cortical stimulation in association with training leads to improvements of motor learning and use-dependent plasticity. The purpose of this protocol is to apply a painless stimulation technique to the motor cortex of the affected hemisphere of patients with subcortical stroke (transcranial DC stimulation, tDCS) to test the hypothesis that tDCS of the motor cortex of the affected hemisphere in association with motor training will improve motor learning of a finger sequence in the paretic hand.
Furthermore, recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere. This abnormality might adversely influence motor recovery. Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere to test the hypothesis that reduction of the inhibitory influence of the unaffected hemisphere over the affected in association with motor training will improve motor learning.
This technique has been so far applied in several hundred subjects worldwide in the absence of undesirable side effects reported to date.
We plan to study patients with chronic strokes and healthy age- and gender matched normal volunteers. Primary outcome measure will be the number of correct keyboard piano sequences played in a specific time-period (30 seconds). Secondary outcome measures are speed of tapping with only one finger; simple reaction times; pinch force; and a functional measure of activities of daily life (ADL): Jebsen-Tailor-Test. To better understand the mechanisms underlying the proposed behavioral gains, we will use TMS to identify changes in corticomotor excitability.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 3 months after the stroke.
- We will choose Patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. Assessment of the initial functional state will be taken either from patient report or medical records.
- As the control group, we will include age- and gender matched Normal Volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients).
Key exclusion criteria (12 listed)
- Patients with more than one stroke in the medical cerebral artery territory.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients or Normal Volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2).
- Patients or Normal Volunteers with 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 of 23 or less).
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 11723286Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
- Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Background: PubMed 7675082Karni A, Meyer G, Jezzard P, Adams MM, Turner R, Ungerleider LG. Functional MRI evidence for adult motor cortex plasticity during motor skill learning. Nature. 1995 Sep 14;377(6545):155-8. doi: 10.1038/377155a0.
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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 Cerebrovascular Accident, 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 3 inclusion and 12 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 NCT00067197, which also lists 3 linked publications.
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.