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

NCT00314769 | Completed

• 2 other identifiers: 06013806-N-0138
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Keywords

Transcranial Direct Current Stimulation (TDCS); Motor Learning; Transcranial Magnetic Stimulation (TMS); Cortical Re-Organization; Neuroplasticity; Neurorehabilitation; TBI; Stroke; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include HEALTHY VOLUNTEERS under the following circumstances:
• Age of 18 to 80 years.
• Written informed consent is given by the participant.
• Mini-Mental-Status examination greater than 23 points.
• Handedness as assessed by Edinburgh handedness inventory shows a laterality index (LI) greater than 75 (dexterity) or LI of less than -75 (left-handedness).
• Ability to concentrate and to perform the tasks required in the present study.
• Commitment to participate in the long-term follow-up (up to 3 months).
• We will include STROKE PATIENTS under the following circumstances:
• Age of 18 to 80 years.
• Stroke more than 3 months ago.
• Single stroke with hemispheric lesions.
• Stroke that affected one side of the brain (unilateral stroke).
• 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.
• Commitment to participate in the long-term follow-up (up to 3 months).
• Written informed consent is given by the patient.

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).
• Both sides of the brain are affected by the stroke or clear bilateral motor impairment.
• TBI from penetrating gunshot or explosive trauma.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• United States Department of Defense: collaborator
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• National Institutes of Health Clinical Center (CC): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1073/pnas.97.7.3661.

  PMID: 10716702 BACKGROUND

• 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. doi: 10.1073/pnas.95.3.861.

  PMID: 9448252 BACKGROUND

• 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. doi: 10.1152/jn.1998.80.4.2177.

  PMID: 9772270 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 14, 2006
• Study Start: April 7, 2006
• Study Completion: December 16, 2013
• Last Updated: December 16, 2019

Record last verified: 2013-12-16

Locations

US (1)