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Protocol Details

Influence of Brain Oscillation-Dependent TMS on Motor Function

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0168

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)

None

Special Instructions

Currently Not Provided

Keywords

Stroke

Recruitment Keyword(s)

None

Condition(s)

Stroke;
Normal Physiology;
Aging

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

When people have a stroke, they often have difficulty moving their arms and hands. Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke can move their arms and hands. But the effects of TMS are minor, and it doesn t work for everyone. Researchers want to study how to time brain stimulation so that the effects are more consistent.

Objective:

To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved.

Eligibility:

Adults ages 18 and older who had a stroke at least 6 months ago

Healthy volunteers ages 60 and older

Design:

Participants will have up to 5 visits.

At visit 1, participants will be screened with medical history and physical exam. Participants with stroke will also have TMS and surface electromyography (sEMG).

For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple movements during TMS.

For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded.

At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noise.

At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG, small electrodes on the scalp will record brainwaves. Participants will sit still, watch a movie, or do TMS.

Participants may be asked to have 2 extra visits to redo procedures.

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Eligibility

INCLUSION CRITERIA:

-Healthy older adults:

--Age 60 and over

--Willingness/ability to provide informed consent

Stroke patients:

--Age 18 and over

--Unilateral or bilateral upper limb hemiparesis with the ability to voluntarily contract a finger, hand, wrist, or elbow muscle in the affected arm(s)

--Stroke onset > 6 months prior to participation

--Intact M1 sufficient to induce motor evoked potentials in the affected upper extremity following ipsilesional TMS, as evaluated during the TMS Screening.

--Willingness/ability to provide informed consent

---If the investigator feels the individual s capacity to provide informed consent is questionable, the NIH Human Subjects Protection Unit (HSPU) will be requested to determine the individual s ability to consent.

EXCLUSION CRITERIA:

-Healthy older adults:

--Presence of severe neurological or medical disorder (e.g. Parkinson s disease or multiple sclerosis)

--History of seizures

--Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), tri-cyclic or other anti-depressants, benzodiazepines or prescription stimulants

--MRI contraindications, as per NMR Center MRI Safety Screening Questionnaire, such as metal implants and pregnancy. Pregnancy for women of childbearing potential will be assessed using pregnancy test within 24 hours preceding MRI procedures.

--TMS contraindications, such as:

---Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull

---Diagnosed severe hearing loss

--Staff from our section

-Stroke patients:

--Presence of severe neurological or medical disorder, other than stroke (e.g. Parkinson s disease or multiple sclerosis)

--History of brainstem stroke

--History of seizures

--Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), benzodiazepines or prescription stimulants

--MRI contraindications, as per NMR Center MRI Safety Screening Questionnaire, such as metal implants and pregnancy. Pregnancy for women of childbearing potential will be assessed using pregnancy test within 24 hours preceding MRI procedures.

--TMS contraindications, such as:

---Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull

---Diagnosed severe hearing loss

--Staff from our section


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Citations:

Not Provided

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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)



Margaret K. Hayward, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D51A
10 CENTER DR
BETHESDA MD 20814
(301) 451-1335
mimi.hayward@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03288220

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