RECRUITING

Cervical Transcutaneous SCS for TBI

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

The goal of this study is to test the effects of non-invasive electrical stimulation of the spinal cord (called transcutaneous spinal cord stimulation, or tSCS) on arm and hand movement in people with motor impairments after a traumatic brain injury (TBI). Specifically, tSCS will be delivered using adhesive electrode pads placed on the skin over the upper back. The research team will measure how tSCS affects strength, movement control and muscle spasticity using different tests. Results of this study will help develop future treatments using an implanted (invasive) form of spinal cord stimulation to improve arm and hand function, helping people with TBI become more independent and improve their quality of life.

Official Title

Effects of Transcutaneous Cervical Spinal Cord Stimulation on Upper Limb Motor Function After Traumatic Brain Injury

Quick Facts

Study Start:2025-11-01
Study Completion:2029-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07147816

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:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a suffered a traumatic brain injury resulting in impairments in arm and hand motor function at least one year prior to enrollment.
  2. * Participants must be between the ages of 21 and 70 years old.
  3. * Participants must have full range of motion in their upper limbs;
  4. * Participants must be between the ages of 21 and 70 years old.
  1. * Participants with severe behavioral or cognitive impairments (e.g., aphasia, apraxia, visual neglect) that could preclude their ability to participate in the study.
  2. * Participants diagnosed with Paroxysmal Sympathetic Hyperactivity (PSH);
  3. * Participants with post-TBI heterotopic ossification or tendon contractures that restricts passive range of motion of upper limb joints;
  4. * Participants with uncontrolled epilepsy or untreated seizure disorders;
  5. * Participants with implanted electronic devices, such as pacemakers and spinal cord stimulators;
  6. * Participants taking benzodiazepine for spasticity;
  7. * Participants with serious disease or disorder (ex. neurological condition other than TBI, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.
  8. * Female participants must not be pregnant or breast feeding.
  9. * Evaluation to sign consent form score \<12.

Contacts and Locations

Study Contact

Amy Boos, MS
CONTACT
412-648-4179
amy.boos@pitt.edu
Roberto M de Freitas, PhD
CONTACT
412-383-1077
rmd110@pitt.edu

Principal Investigator

Roberto M de Freitas, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Roberto de Freitas

  • Roberto M de Freitas, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2025-11-01
Study Completion Date2029-11-01

Study Record Updates

Study Start Date2025-11-01
Study Completion Date2029-11-01

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Stimulation
  • Transcutaneous Spinal Cord Stimulation
  • SCS
  • tSCS

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • TBI (Traumatic Brain Injury)