Protocol Number: 07-N-0122

Title:

Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System

Number:

07-N-0122

Summary:

This study will explore the effects of different combinations of brain, hand or leg stimulation on hand movement.

Healthy normal volunteers 18 years of age or older may be eligible for this study. Candidates are screened with a medical and neurological history and examination.

The study involves one to twenty 4-hour experimental sessions completed over 1 to 12 months. During each session, participants receive some combination of mild electrical peripheral nerve stimulation, magnetic transcranial stimulation (TMS), and electrical transcranial stimulation (TMS and tDCS, respectively). No more than two forms of stimulation are combined during any one session, with no more than 3 hours of stimulation during the session.

Each session includes some of the following tests:

-Surface electromyography: Electrodes filled with a conductive gel are taped to the skin to measure and record the electrical activity of the nerves and muscles of the arm or leg.

-TMS measurements: A wire coil is held on the scalp. 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 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 various places on 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.

-Peripheral nerve stimulation: Two pairs of electrodes are placed on the arm or leg to stimulate and record from the nerves and muscles beneath them.

-Magnetic resonance imaging (MRI): The subject lies on a bed that slides into a tubular scanner surrounded by a strong magnetic field. Earplugs are worn to muffle loud noises that occur during the scanning. The procedure lasts about 60 minutes, with the subject asked to lie still for up to 20 minutes at a time.

-Motor function tests: Subjects perform motor function tests at the beginning and end of each session. The tests might include pinching a force-measuring instrument with their fingers, pressing keys on a keyboard as fast as possible, inserting pegs into a pegboard, lifting weights, flipping cards, and others.

-Questionnaires: Subjects complete questionnaires at the end of each session to rate their fatigue, loss of attention and pain or other discomfort.

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:

Age 18 and older

Willingness and ability to give consent

Normal neurological examination

Clearly dominant handedness (right or left) as assessed by Handedness scales

EXCLUSION CRITRIA:

Recent or ongoing history of severe alcohol or drug abuse

Any severe or progressive neurological disorder or severe medical condition

Chronic use of medications acting primarily on the central nervous system, which lower the seizure threshold or significantly alter cortical excitability such as antipsychotic drugs (chlorpromazine, clozapine), tricyclic or other antidepressants, or prescription stimulants

Pregnancy, if partaking in MRI and rTMS> 1Hz

Medical or technical contraindications to MRI procedures or devices producing artifacts that impair MRI signal (e.g., dental braces, pacemakers, implanted medication pumps, cochlear devices, neural stimulators, metal in the cranium, surgical clips, and other metal/magnetic implants, claustrophobia)

History of epilepsy

Special Instructions:

Currently Not Provided

Keywords:

Transcranial Direct Current Stimulation (tDCS)

Transcranial Magnetic Stimulation (TMS)

Peripheral Nerve Stimulation

Primary Motor Cortex

Corticomotor Excitability

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Healthy

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):

Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16.

Pascual-Leone A, Valls-Sole J, Wassermann EM, Hallett M. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain. 1994 Aug;117 ( Pt 4):847-58.

Muellbacher W, Ziemann U, Boroojerdi B, Hallett M. Effects of low-frequency transcranial magnetic stimulation on motor excitability and basic motor behavior. Clin Neurophysiol. 2000 Jun;111(6):1002-7.

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