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

Completed

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID: NCT00314769
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 196
Starts: 2006-04-07
Expected to finish: 2013-12-16
Last updated by the study team: 2019-12-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

We will exclude healthy volunteers and stroke patients, and TBI patients if one of the following conditions applies:
Unable to perform the tasks.
A history of severe neurological illness, e.g. brain tumor, epilepsy or a history of symptomatic seizures, polyneuropathy etc.
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).
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).
Increased intracranial pressure as evaluated by clinical means (presence of papilledema in eye ground exam, compressed sulci/ventricle on MRI scan).
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.
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).
Any visual disturbances, especially visual acuity less than 60%.
Diseased or damaged skin over the face or scalp.
Acute or chronic tendosynovitis, severe rheumatoid arthritis, active joint deformity of arthritic origin, according to the hand.
Professionally practiced playing a musical instrument or trained as a typist.
Pregnancy (for the MRI component only).
EXCLUSION CRITERIA - FOR STROKE PATIENTS ONLY:
Both sides of the brain are affected by the stroke or clear bilateral motor impairment.
EXCLUSION CRITERIA - FOR TBI PATIENTS ONLY:
TBI from penetrating gunshot or explosive trauma.
Post-traumatic seizures
No reported changes in both the Glascow Coma Scale and mental status following injury.
Active depression of any severity with psychoactive medication changes in the last 2 months.
Active psychosis, disruptive or violent behavior, or poor motivational capacity.
Pending litigation regarding the trauma

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.