Health TrialsbyHealthPanel

Epidural Stimulation for Upper Extremity Function

ConditionsSpinal Cord Injury CervicalTetraplegia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.

At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.

The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Percutaneous spinal cord stimulation

    Device

    The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Percutaneous spinal cord stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Nerve transfer recipient muscle strength

Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome.

Time frame
0-6 weeks

Secondary outcomes

1

Nerve transfer recipient muscle force

Change in muscle force generated by recipient nerve transfer muscle group with spinal cord stimulation activated. Muscle force is measured with a hand-held dynamometer. This is measured in Newtons, with a larger number meaning greater force and a better outcome.

Time frame
0-6 weeks
2

Neck and upper extremity pain

Change in neck and upper extremity pain measured with the Numeric Rating Scale (NRS). NRS scale ranges from 0 (No pain) to 10 (worst possible pain), with a lower number representing a better outcome. A positive change in NRS from baseline to follow-up visits suggests improvement of pain.

Time frame
0-6 weeks
3

Amplitude of percutaneous stimulation

Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes.

Time frame
0-4 weeks
4

Frequency of percutaneous stimulation

Optimized frequency of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Frequency is measured in Hz (Hertz).

Time frame
0-4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: