Long-Term Improvement in Motor Learning by Transcranial Direct Current Stimulation

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT00314769
• Date of registration: 13/04/2006
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Long-Term Improvement in Motor Learning by Transcranial Direct Current Stimulation
• Scientific title: Long-Term Improvement in Training Effects by Transcranial DC Stimulation
• Date of first enrolment: April 2006
• Target sample size: 337
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00314769
• Study type: Observational
• Study design: N/A

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)

• Name: Rita Volochayev, C.R.N.P.

• Name: Leonardo G Cohen, M.D.
• Affiliation: National Institute of Neurological Disorders and Stroke (NINDS)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

We will include HEALTHY VOLUNTEERS under the following circumstances:

1. Age of 18 to 80 years.

2. Written informed consent is given by the participant.

3. Mini-Mental-Status examination greater than 23 points.

4. Handedness as assessed by Edinburgh handedness inventory shows a laterality index
(LI) greater than 75 (dexterity) or LI of less than -75 (left-handedness).

5. Ability to concentrate and to perform the tasks required in the present study.

6. Commitment to participate in the long-term follow-up (up to 3 months).

We will include STROKE PATIENTS under the following circumstances:

1. Age of 18 to 80 years.

2. Stroke more than 3 months ago.

3. Single stroke with hemispheric lesions.

4. Stroke that affected one side of the brain (unilateral stroke).

5. Patients with initially severe motor paresis (below MRC grade 2), who subsequently
recovered to the point that they have a residual motor deficit but still able to
perform the tasks required by the study.

6. Commitment to participate in the long-term follow-up (up to 3 months).

7. Written informed consent is given by the patient.

8. Mini-Mental-Status examination greater than 23 points.

9. Handedness as assessed by Edinburgh handedness inventory shows a laterality index
(LI) greater than 75 (dexterity) or LI of less than -75 (left-handedness).

We will include TBI PATIENTS under the following circumstances:

1. Age of 18 to 80 years

2. Handedness as assessed by Edinburgh handedness inventory showing a laterality index
(L1) greater than 75 (dexterity) or L1 of less than -75 (left-handedness)

3. Ability to concentrate on a computer task for up to an hour.

4. Ability to perform dominant hand thumb opposition against resistance.

5. Willingness to commit to the time involved in the study.

6. Willingness and ability to give consent.

7. TBI occurred from non-penetrating blunt, acceleration, or deceleration forces to the
head.

8. TBI is of mild to moderate severity, based on loss of consciousness up to 24 hours,
post-traumatic amnesia up to 7 days, or GCS score (9-15), as can be ascertained by
medical records or patient report.

9. TBI more than 6 months ago

EXCLUSION CRITERIA:

We will exclude healthy volunteers and stroke patients, and TBI patients if one of the
following conditions applies:

1. Unable to perform the tasks.

2. A history of severe neurological illness, e.g. brain tumor, epilepsy or a history of
symptomatic seizures, polyneuropathy etc.

3. A history of severe alcohol or drug abuse, psychiatric illness such as 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).

4. More than moderate uncontrolled medical problems (e.g. active cancer or renal
disease, any kind of end-stage pulmonary or cardiovascular disease,
hypo/hyperthyroidism, severe diabetes, peripheral arteriopathy, or a deteriorated
condition due to age, or other medical conditions as determined by the study
physician, that would interfere with participation in this study).

5. Increased intracranial pressure as evaluated by clinical means (presence of
papilledema in eye ground exam, compressed sulci/ventricle on MRI scan).

6. Metal in the body which might make having an MRI unsafe (e.g., vascular clips,
cochlear implant) in the cranium (except in the mouth), pacemaker, implanted
medication pumps, neural stimulators.

7. Drug treatment acting primarily on the central nervous system which lowers the
seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or
tricyclic antidepressants (for the TMS component only).

8. Any visual disturbances, especially visual acuity less than 60%.

9. Diseased or damaged skin over the face or scalp.

10. Acute or chronic tendosynovitis, severe rheumatoid arthritis, active joint deformity
of arthritic origin, according to the hand.

11. Professionally practiced playing a musical instrument or trained as a typist.

12. Pregnancy (for the MRI component only).

EXCLUSION CRITERIA - FOR STROKE PATIENTS ONLY:

13. Both sides of the brain are affected by the stroke or clear bilateral motor
impairment.

EXCLUSION CRITERIA - FOR TBI PATIENTS ONLY:

14. TBI from penetrating gunshot or explosive trauma.

15. Post-traumatic seizures

16. No reported changes in both the Glascow Coma Scale and mental status following
injury.

17. Active depression of any severity with psychoactive medication changes in the last 2
months.

18. Active psychosis, disruptive or violent behavior, or poor motivational capacity.

19. Pending litigation regarding the trauma



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Secondary ID(s)

06-N-0138

060138

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Center for Neuroscience and Regenerative Medicine (CNRM)

Department of Defense

National Institutes of Health Clinical Center (CC)