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Protocol Details

modulation of motor function by Stimulation of the Central and Peripheral Nervous System

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

07-N-0122

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

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

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.

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Eligibility

INCLUSION CRITERIA:

1) Age 18 and older

2) Willingness and ability to give consent

3) Normal neurological examination

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

EXCLUSION CRITERIA:

1) Any severe or progressive neurological disorder or severe medical condition, or history of seizures

2) 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.

3) Pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments

4) Diagnosis of drug dependence made by a health care provider (ICD-9-CM code 304)


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Citations:

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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Contacts:

Principal Investigator

Referral Contact

For more information:

Leonardo G. Cohen, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D54
10 CENTER DR
BETHESDA MD 20814
(301) 496-9782
cohenl1@mail.nih.gov

Rita Volochayev, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D51
10 CENTER DR
BETHESDA MD 20814
(301) 402-0546
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:

NCT00453505

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