Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT04286516

Conditions

Stroke

Brain Disease

Central Nervous System Diseases

Nervous System Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief summary:

The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS.

Conditions

Stroke

Brain Disease

Central Nervous System Diseases

Nervous System Diseases

Cardiovascular Diseases

Study ID

NCT04286516

Start date

Jan 10, 2020

Status verified date

May, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Inclusion Criteria (control participants):

  • Be 45-90 years of age
  • Have adequate language and neurocognitive function to participate in training and testing
  • Be medically stable to participate in the study
  • Be English speaking

Inclusion Criteria (participants with stroke):

  • Be 45-90 years of age
  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
  • Stroke onset at least 6 months before enrollment
  • Subcortical stroke (ex: internal capsule, deep white matter of posterior frontal lobe)
  • Present with mild to moderate arm dysfunction
  • Be medically stable to participate in the study
  • Be English speaking

Exclusion Criteria:

(for both groups)

  • Unable to give informed consent
  • Have a serious complicating medical illness that would preclude participation
  • Contractures or orthopedic problems limiting range of joint motion in the potential study arm or other impairments that would interfere with the study activities
  • Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
  • Unable to comply with requirements of the study
  • Enrollment in another greater-than-minimal risk study
  • Presence of medical condition or implant that prevents safe administration of TMS or MRI
  • Pregnancy

Study Design

Enrollment

76 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reaching with TMS

All participants enrolled in this group will receive TMS while performing reaching movements in a robotic system.

Interventions

Transcranial Magnetic Stimulation

Paired pulse transcranial magnetic stimulation

Primary outcome measure

  • Path length [ Time Frame: Immediate (within 2 s after stimulation) ]

Central Contacts and Locations

Central contacts

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Principal Investigator:

George F. Wittenberg, MD PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-02.