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Search / Trial NCT05736653

PCMS Task After Moderate-to-severe Stroke

Launched by UNIVERSITY OF UTAH · Feb 10, 2023

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Stroke Hand Brain Stimulation

ClinConnect Summary

Researchers at the University of Pittsburgh are conducting a study to find out if a combination of brain, nerve, and hand stimulation can help improve hand movement in people who have had a moderate to severe stroke. This study aims to see if this combined therapy can strengthen the connection between the brain and the hand muscles that are weak after a stroke, and whether it can also help participants move their hands better and perform daily tasks more effectively.

To be eligible for this study, participants should be aged between 18 and 85 and must have had their first stroke at least six months ago. They should be able to grasp a small object and have sufficient cognitive ability to engage in the study. However, individuals with certain conditions, such as severe muscle stiffness, other neurological disorders, or those who cannot undergo MRI scans due to medical implants, will not be included. Participants can expect to receive specialized stimulation treatments and will be monitored to assess how their hand movement improves over the course of the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age between 18-85 years
  • 2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
  • 3. Stroke onset of at least six months prior to the time of participation
  • 4. A score of at least 1 out of 2 on the spherical grasping item of the Fugl-Meyer Upper Extremity Subscale to allow participants to grasp the ball
  • 5. Cognitive skills to actively participate, as indicated by scores of \> 23 on the Mini-Mental Status Examination
  • 6. English speaking
  • Exclusion Criteria:
  • 1. Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction
  • 2. Presence of severe aphasia
  • 3. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score \>2
  • 4. Diagnosis of neurological disorders other than stroke
  • 5. History of seizure or epilepsy
  • 6. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
  • 7. Presence of metallic implants in the head or neck
  • 8. Currently or planning to become pregnant
  • 9. Difficulty maintaining alertness or remaining still
  • 10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI)
  • 11. Bodyweight \> 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
  • 12. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
  • 13. Life expectancy less than the duration of the study
  • 14. Excessive pain in the paretic hand, defined as a Visual Analog Scale Score \>4
  • 15. Participation in concurrent occupational therapy
  • 16. Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA)

About University Of Utah

The University of Utah is a prestigious research institution known for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. With a robust infrastructure that supports a wide range of biomedical research initiatives, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies. By fostering collaboration among researchers, clinicians, and community partners, the University of Utah aims to translate scientific discoveries into effective therapies and interventions, ultimately enhancing health outcomes and contributing to the advancement of medical science.

Locations

Pittsburgh, Pennsylvania, United States

Salt Lake City, Utah, United States

Patients applied

0 patients applied

Trial Officials

Amit Sethi, PhD

Principal Investigator

University of Utah

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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