Protocol Number: 06-N-0138

Title:

Long-Term Improvement in Training Effects by Transcranial DC Stimulation

Number:

06-N-0138

Summary:

This study will examine whether continuous use of transcranial direct current stimulation (tDCS) in combination with motor training can lead to long-term improvement in movement performance beyond what can be achieved with motor training alone.

Healthy normal volunteers 18-80 years of age who are clearly right- or left-handed may be eligible for this study. Each candidate is screened with a medical history, clinical and neurological examination, questionnaires to evaluate memory, attention, and handedness and a brain MRI, if one has not been done by NINDS within 12 months of entering the study. Pregnant women may not participate.

The study involves 10 sessions (in addition to the screening visit) over 3 months. Sessions 1-5 are completed over 5 consecutive days. Sessions 6-10 are divided over the remaining time. Participants are randomly assigned to one of three groups: 1) tDCS during motor training; 2) tDCS after training; or 3) training with sham tDCS. During these sessions, participants perform a pinch force task (squeezing a small device between the thumb and forefinger) and visuomotor tasks (using a device to move the cursor on a computer screen to various targets and holding the cursor in place for 1 second).

During the motor training and performance sessions, participants have the following procedures.

-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.

-Surface electromyography: Electrodes are filled 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

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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).

EXCLUSION CRITERIA:

We will exclude healthy volunteers and stroke 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. Previous implantation of metallic material (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:

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

Special Instructions:

Currently Not Provided

Keywords:

Transcranial Direct Current Stimulation (tDCS)

Motor Learning

Transcranial Magnetic Stimulation (TMS)

Cortical Re-Organization

Neuroplasticity

Neurorehabilitation

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Healthy Volunteers

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Butefisch CM, Davis BC, Wise SP, Sawaki L, Kopylev L, Classen J, Cohen LG. Mechanisms of use-dependent plasticity in the human motor cortex. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3661-5.

Karni A, Meyer G, Rey-Hipolito C, Jezzard P, Adams MM, Turner R, Ungerleider LG. The acquisition of skilled motor performance: fast and slow experience-driven changes in primary motor cortex. Proc Natl Acad Sci U S A. 1998 Feb 3;95(3):861-8. Review.

van Mier H, Tempel LW, Perlmutter JS, Raichle ME, Petersen SE. Changes in brain activity during motor learning measured with PET: effects of hand of performance and practice. J Neurophysiol. 1998 Oct;80(4):2177-99.

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