Healthy Volunteer Clinical Trial
Official title:
Neural Substrates of Lasting Motor Skill Learning by Spacing Effect
| Verified date | December 16, 2013 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will explore the optimum training schedule for stroke patients to learn motor
skills. It will see if motor training is more effective when training sessions are
distributed over time (spaced training) or when the sessions are scheduled close together
(massed training). The results of this study may help researchers devise the best training
schedule for patients to derive the maximum benefit from rehabilitation therapy.
Healthy normal volunteers and people who have had a stroke may be eligible for this study.
Patients must be 3 months post-stroke. All participants must be right-handed and between 18
and 80 years of age.
Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS).
Hand muscle activity is measured using surface electromyography (EMG). Pinch training
involves training the participant to pinch as strongly as possible, using a device that
records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical
current is passed through the coil, creating a magnetic pulse that stimulates the brain. The
subject hears a click and may feel a pulling sensation on the skin under the coil. There may
be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal
disks) are filled with a conductive gel and taped to the skin over the muscle.
Following one practice session of pinch task training and TMS, participants have four
training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the
practice session.
For the 4- to 5-hour practice session, subjects do the following:
- Perform a single session of pinch motor task for familiarization
- Undergo TMS to measure brain activity
- Practice five 6-minute blocks of pinch motor task with rest periods between sessions and
perform a calculation task (addition and subtraction tasks) during each rest period
- Receive TMS over 15 minutes. (Some sessions may have sham TMS.)
- Read books and magazines during a 45-minute rest period
- Perform a single block of the pinch motor task
- Undergo TMS to measure brain activity
- Complete a questionnaire that measures attention, fatigue and mood
For the remaining four sessions, participants perform one practice block and TMS. Each
session lasts about 2 hours.
| Status | Completed |
| Enrollment | 213 |
| Est. completion date | December 16, 2013 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
- INCLUSION CRITERIA: Healthy Volunteers - Age between 18-80 years - Able to perform tasks required by the study<TAB> - Willing and able to give consent - Have a normal physical and neurological examination - Right Handed as assessed by the Edinburgh inventory scale (Edinburgh, 1971) EXCLUSION CRITERIA: Healthy Volunteers - History of alcohol or drug abuse, and psychiatric illness such as severe depression. - Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants. INCLUSION AND EXCLUSION CRITERIA FOR STROKE PATIENTS: Patients must be between the ages of 18 and 80 years of age, inclusive. Included will be those with chronic (more than 3 months) stroke who recovered motor function to the point of being able to perform the ballistic pinch force task. Stroke patients will be recruited through the NIH Clinical Research Volunteer Program. Assessment of severity of initial hemiparesis will be taken either from patient report or medical records. EXCLUDED FROM THE STUDY WILL BE PATIENTS: 1. with a history of severe alcohol or drug abuse, psychiatric illness like severe depression, severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam (Folstein, 1976) score of 23 or less) 2. with 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) 3. with metal in the body (metal in the cranium, metal fragments from occupational exposure, surgical clips in or near the brain, cardiac or neural pacemakers, intracardiac lines, implanted medication pumps, blood vessel, cochlear or eye implants) 4. with history of loss of consciousness or epilepsy 5. with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants. |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Bermpohl F, Fregni F, Boggio PS, Thut G, Northoff G, Otachi PT, Rigonatti SP, Marcolin MA, Pascual-Leone A. Effect of low-frequency transcranial magnetic stimulation on an affective go/no-go task in patients with major depression: role of stimulation site and depression severity. Psychiatry Res. 2006 Jan 30;141(1):1-13. Epub 2005 Dec 13. — View Citation
Bermpohl F, Fregni F, Boggio PS, Thut G, Northoff G, Otachi PT, Rigonatti SP, Marcolin MA, Pascual-Leone A. Left prefrontal repetitive transcranial magnetic stimulation impairs performance in affective go/no-go task. Neuroreport. 2005 Apr 25;16(6):615-9. — View Citation
Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. — View Citation
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