Explore the NIHProtocol Details
Long-Term Improvement in Training Effects by Transcranial DC Stimulation
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
06-N-0138 |
Sponsoring Institute |
National Institute of Neurological Disorders and stroke (NINDS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Transcranial Direct Current Stimulation (tDCS); |
Recruitment Keyword(s) |
Healthy Volunteer; |
Condition(s) |
Healthy Volunteers |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
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
Eligibility
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
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Leonardo G. Cohen, M.D. National Institute of Neurological Disorders and stroke (NINDS) National Institutes of Health BG 10 RM 7D54 MSC 1428 10 CENTER DR BETHESDA MD 20892-1428 (301) 496-9782 cohenl1@mail.nih.gov |
Rita Volochayev, C.R.N.P. National Institute of Neurological Disorders and stroke (NINDS) National Institutes of Health BG 10 RM 7D51 MSC 1428 10 CENTER DR BETHESDA MD 20892-1428 (301) 451-1335 volochar@mail.nih.gov |
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 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00314769
QUESTIONS?
Contact the Patient Recruitment and Public Liaison Office for:
- Details on how to participate in a study
- Details on how to refer a patient to a study
NIH Clinical Studies Information Request
Contact the Office of Communications for:
- General information about the NIH Clinical Center
Contact the Department Clinical Research Informatics, (DCRI) for:
- Technical questions about Adobe Acrobat and the PDF format
- Technical questions about this web server
