RECRUITING

PCMS Task After Moderate-to-severe Stroke

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

Researchers at the University of Pittsburgh are conducting a research study to see how combining brain, nerve, and hand stimulation affect hand movement after stroke. The primary purpose of this study is to examine changes in the connection between the brain and the weak hand muscles after the combined brain, nerve, and hand stimulation. The primary hypothesis is that the combined brain, nerve, and hand stimulation will increase the the connection between the brain and the weak hand muscles. The secondary purpose of this study is to examine changes in weak hand's movement and function after the combined brain, nerve, and hand stimulation. The secondary hypothesis is that the combined brain, nerve, and hand stimulation will increase weak hand movement and function.

Official Title

Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke

Quick Facts

Study Start:2023-06-29
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05736653

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 to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age between 18-85 years
  2. 2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
  3. 3. Stroke onset of at least six months prior to the time of participation
  4. 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. 5. Cognitive skills to actively participate, as indicated by scores of \> 23 on the Mini-Mental Status Examination
  6. 6. English speaking
  1. 1. Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction
  2. 2. Presence of severe aphasia
  3. 3. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score \>2
  4. 4. Diagnosis of neurological disorders other than stroke
  5. 5. History of seizure or epilepsy
  6. 6. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
  7. 7. Presence of metallic implants in the head or neck
  8. 8. Currently or planning to become pregnant
  9. 9. Difficulty maintaining alertness or remaining still
  10. 10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI)
  11. 11. Bodyweight \> 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
  12. 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. 13. Life expectancy less than the duration of the study
  14. 14. Excessive pain in the paretic hand, defined as a Visual Analog Scale Score \>4
  15. 15. Participation in concurrent occupational therapy
  16. 16. Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA)

Contacts and Locations

Study Contact

Amit Sethi, PhD
CONTACT
8016467882
amit.sethi@utah.edu

Principal Investigator

Amit Sethi, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Neural Plasticity Rehabilitation and Movement Dynamics Lab
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Amit Sethi, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

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 Date2023-06-29
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2023-06-29
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • Hand
  • Brain stimulation

Additional Relevant MeSH Terms

  • Stroke