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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00453505
First received: March 28, 2007
Last updated: May 21, 2014
Last verified: September 2013
  Purpose

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.

Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: March 2007
Detailed Description:

Objectives

Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), theta-burst TMS (TBS), transcranial direct current stimulation (tDCS) and cutaneous/peripheral nerve stimulation (CPNS) alone or paired with TMS (paired associative stimulation, PAS), has been increasingly used in the investigation of cortical plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that TMS, TBS, tDCS and CPNS can successfully modulate motor function in healthy volunteers, as well as in patients with neurological disorders such as stroke.

One fundamental problem is that the optimal parameters of stimulation to modulate motor function by all of these techniques are not known. The purpose of this protocol is to explore within safe guidelines, the effects of different stimulation parameters on motor cortical function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section (HCPS) in the use of TMS, TBS, tDCS, and CPNS techniques.

We expect that information emerging from these studies will allow us to 1)optimize the stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented hypothesis-driven protocols,2)to collect pilot data for power analysis for future patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these different methods.

Study Population

Up to 1000 healthy volunteers, age 18 and older.

Design

Healthy volunteers will receive one or more of the following types of stimulation alone or in combination: (1) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold intensity (MT) (2) TBS below 100% active MT; (3) tDCS up to 2 mA for up to 60mins (4) PNS with intensities below 130% of the peripherally-elicited-motor-threshold for up to 2 hours. . All of these parameters of stimulation and procedures have safely been used as previously reported in the literature. Sham stimulations will be delivered for each modality.

Each subject may undergo up to 20 sessions spaced by at least one day, depending on the particular exploration. To verify that the number of sessions per subject does not exceed 20 sessions, the number of sessions per participant is tracked across substudies using CTDB. The AIs are responsible for entering into CTDB the subjects/visits. We will test the effects of these different forms of stimulation on motor cortical excitability, simple motor tasks, and functional neuroimaging measures. Some stimulation may be conducted before, after, or during fMRI scans, eye movement recording, MEG and/or EEG recording sessions. To identify the possible contribution of sub-cortical structures, we will also measure M-wave, F-wave, and/or H-Reflexes. The goal of these exploratory studies is to obtain preliminary information on the effects of these various combinations of central and peripheral nervous system stimulation that would allow us to develop subsequent, finely tuned, hypothesis-driven protocols. Hypothesis-driven studies started under this protocol will be limited to 6 subjects per group and accrual of subjects to these hypothesis-driven substudies will be tracked using CTDB.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453505

Contacts
Contact: Rita Volochayev, C.R.N.P. (301) 402-0546 volochar@mail.nih.gov
Contact: Leonardo G Cohen, M.D. (301) 496-9782 cohenl1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leonardo G Cohen, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00453505     History of Changes
Other Study ID Numbers: 070122, 07-N-0122
Study First Received: March 28, 2007
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Transcranial Direct Current Stimulation (tDCS)
Transcranial Magnetic Stimulation (TMS)
Peripheral Nerve Stimulation
Primary Motor Cortex
Corticomotor Excitability
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on July 23, 2014