Trials
Search / Trial NCT06437548

Epidural Stimulation for Upper Extremity Function

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 30, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Spinal Cord Stimulation Percutaneous Peripheral Nerve Transfer

ClinConnect Summary

The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.

At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.

Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.

Week 0-4: Weekly testing of motor fu...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥18 years and ≤65
  • Provides informed consent
  • History of upper extremity nerve transfer \> 6 months prior to enrollment
  • Completion of standard post-nerve transfer occupational therapy
  • Baseline upper extremity strength of \< 5/5 grade with the MRC
  • Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
  • Willing and able to adhere to the study protocol
  • Exclusion Criteria:
  • Central nervous system (CNS) malignancy
  • A contraindication to the SCS procedure
  • Diagnosis that precludes the patient from full participation in the protocol
  • A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
  • Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment
  • For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
  • Other factors that prevent participation in the opinion of the surgeon-principal investigator

Trial Officials

Yi Lu, MD PhD

Study Chair

Brigham and Women's Hospital

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0