Status:
RECRUITING
Cervical Transcutaneous SCS for TBI
Lead Sponsor:
Roberto de Freitas
Collaborating Sponsors:
Chuck Noll Foundation
Conditions:
Traumatic Brain Injury
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
The main goal of this study is to assess the immediate effects of cervical transcutaneous spinal cord stimulation (tSCS) on arm and hand motor functions after traumatic brain injury (TBI). Specificall...
Eligibility Criteria
Inclusion
- TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
- 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.
- Participants must be between the ages of 21 and 70 years old.
- HEALTHY CONTROL SUBJECTS:
- Participants must have full range of motion in their upper limbs;
- Participants must be between the ages of 21 and 70 years old.
Exclusion
- TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
- Participants with severe behavioral or cognitive impairments (e.g., aphasia, apraxia, visual neglect) that could preclude their ability to participate in the study.
- Participants diagnosed with Paroxysmal Sympathetic Hyperactivity (PSH);
- Participants with post-TBI heterotopic ossification or tendon contractures that restricts passive range of motion of upper limb joints;
- Participants with uncontrolled epilepsy or untreated seizure disorders;
- Participants with implanted electronic devices, such as pacemakers and spinal cord stimulators;
- Participants taking benzodiazepine for spasticity;
- 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.
- Female participants must not be pregnant or breast feeding.
- Evaluation to sign consent form score \<12.
- HEALTHY CONTROL SUBJECTS:
- \- Participants who have any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions, etc.) or cognitive impairments that could affect their ability to participate in this study.
Key Trial Info
Start Date :
November 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07147816
Start Date
November 26 2025
End Date
November 1 2029
Last Update
December 2 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213