Epidural Stimulation for Upper Extremity Function

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

Keywords

ClinConnect Summary

This clinical trial is focused on helping people with cervical spinal cord injuries, particularly those with limited hand and arm movement. The goal is to see if a special treatment called cervical epidural spinal cord stimulation can improve hand and arm function after patients have undergone a nerve transfer procedure. Nerve transfer is a surgery that can help some people regain partial movement in their hands or arms, but researchers want to find out if adding spinal cord stimulation can make this recovery even better.

To participate in this study, individuals must be between 18 and 65 years old, have had a nerve transfer for their upper limbs at least six months prior, and have completed therapy for that procedure. They should also be scheduled for spinal cord stimulation due to chronic pain that hasn't improved with standard treatments. Participants will need to follow the study guidelines, and it’s important to note that there are some conditions that would exclude someone from joining, such as having certain types of tumors or other health issues. This trial is not yet recruiting participants, but it aims to explore new possibilities for improving quality of life for those with spinal cord injuries.

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