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NCT Number: NCT06437548

Epidural Stimulation for Upper Extremity Function

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.

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Key information

About this study

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 function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.

Temporary leads will be removed after approximately 4 weeks.

At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous spinal cord stimulation

Device

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

Primary outcomes

  1. Nerve transfer recipient muscle strength

    Time frame: 0-6 weeks

    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.

Secondary outcomes

  1. Nerve transfer recipient muscle force

    Time frame: 0-6 weeks

    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.

  2. Neck and upper extremity pain

    Time frame: 0-6 weeks

    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.

  3. Amplitude of percutaneous stimulation

    Time frame: 0-4 weeks

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

  4. Frequency of percutaneous stimulation

    Time frame: 0-4 weeks

    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).

  5. Pulse width of percutaneous stimulation

    Time frame: 0-4 weeks

    Optimized pulse width of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Pulse width is measured in microseconds.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin R. Johnston, MD PhD

CONTACT

[email protected]

(617) 525-7378

Joshua I. Chalif, MD PhD

CONTACT

[email protected]

(617) 525-7378

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Spinal Cord Stimulation for Reanimation After Nervous System Injury

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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