RECRUITING

Influence of Brain Oscillation-Dependent TMS on Motor Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 50 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.

Official Title

Influence of Brain Oscillation-Dependent TMS on Motor Function

Quick Facts

Study Start:2018-09-11
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03288220

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy younger adults:
  2. * Ages 18 years to less than 50 years. (18 to 49)
  3. * Willingness/ability to provide informed consent.
  4. * Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening.
  5. * Healthy older adults:
  6. * Age 50 and over
  7. * Willingness/ability to provide informed consent.
  8. * Ability to induce a motor evoked potential in the muscle target of the upper extremity, as evaluated during the TMS Screening.
  9. * Stroke patients:
  10. * Age 18 and over.
  11. * Unilateral or bilateral upper limb paresis with the ability to voluntarily contract a finger, hand, wrist, or elbow muscle in the affected arm(s).
  12. * Stroke onset \> 6 months prior to participation.
  13. * Intact M1 sufficient to induce motor evoked potentials in the affected upper extremity following ipsilesional TMS, as evaluated during the TMS Screening.
  14. * Willingness/ability to provide informed consent.
  15. * 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.
  1. * Healthy younger and older adults:
  2. * Presence of severe neurological or medical disorder (e.g., Parkinson s disease or multiple sclerosis).
  3. * History of seizures.
  4. * Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), tri-cyclic or other anti-depressants, benzodiazepines, or prescription stimulants.
  5. * TMS contraindications, such as:
  6. * Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside the eye or skull.
  7. * Diagnosed severe hearing loss.
  8. * Current pregnancy.
  9. * Staff from our section.
  10. * Stroke patients:
  11. * Presence of severe neurological or medical disorder, other than stroke (e.g., Parkinson s disease or multiple sclerosis).
  12. * History of brainstem stroke.
  13. * History of seizures.
  14. * Chronic use of antipsychotic drugs (e.g., chlorpromazine or clozapine), benzodiazepines, or prescription stimulants.
  15. * TMS contraindications, such as:
  16. * Pacemaker, implanted pump, stimulator, cochlear implant, or metal objects inside
  17. * Current pregnancy.
  18. * Staff from our section.

Contacts and Locations

Study Contact

Tasneem F Malik, C.R.N.P.
CONTACT
(301) 451-1335
tasneem.malik@nih.gov
Leonardo G Cohen, M.D.
CONTACT
(301) 496-9782
cohenl1@mail.nih.gov

Principal Investigator

Leonardo G Cohen, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Leonardo G Cohen, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-11
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2018-09-11
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • Natural History

Additional Relevant MeSH Terms

  • Healthy
  • Stroke
  • Normal Physiology
  • Aging