Spinal Cord Stimulation for Lower Extremity Function

May 27, 2024 updated by: Yi Lu, MD PhD, Brigham and Women's Hospital

Epidural Spinal Cord Stimulation for Lower Extremity Motor Function in Spinal Cord Injury

This prospective clinical study will investigate the ability of different spine imaging characteristics to predict ambulation recovery responsiveness using epidural spinal cord stimulator (SCS) in patients with chronic incomplete spinal cord injury (SCI).

Epidural spinal cord stimulation below the level of injury can restore previously lost lower extremity voluntary motor function for some patients. The goal of this study is to establish whether spine imaging can be utilized as a biomarker to predict which patients will respond to spinal cord stimulation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ten patients with chronic spinal cord injury who are scheduled to receive a spinal cord stimulator for refractory chronic pain will be recruited throughout the Mass General Brigham health system. At baseline, participants will undergo a neurologic strength exam, Magnetic Resonance Imaging (MRI) of the spine and brain, electromyography (EMG) of the lower extremities, and will complete a battery of pain, motor function and quality of life questionnaires.

Phase 1: The SCS Optimization phase consists of weekly research visits during the first month post-SCS implant. Settings of the spinal cord stimulator parameters will be modified for activation and optimal voluntary control of lower extremity muscles.

Phase 2: The Individualized Neurorehabilitation phase consists of 4 weekly visits for a 5-month period. Participants will undergo neurorehabilitation with the stimulation settings turned on for motor control. Neurorehabilitation will be individualized and will progressively increase participants' physical activity, including assisted/independent standing, stepping and ambulation within safe limits. Participants will undergo monthly muscle strength and surface EMG testing.

At the end of each research visit or neurorehabilitation session, SCS settings will be adjusted to the original pain management parameters.

At the 6-month follow up participants will undergo a neurologic strength exam, MRI of the spine and brain, EMG of the lower extremities and a battery of questionnaires. After the last follow up visit, participants will have the opportunity to continue a long-term follow up or exit the study. SCS parameters will be adjusted to the pain management settings.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years
  • Provides informed consent
  • Eligible for and undergoes SCS implant for chronic low back or leg pain refractory to first-line therapy
  • Stable SCI secondary to a single insult
  • C6-T10 level of injury
  • SCI has occurred >12 months prior to enrollment
  • Chronic low back pain refractory to first-line therapy
  • Current AIS grade B-C, with spared sensation
  • Willingness and ability to adhere to the protocol

Exclusion Criteria:

  • History or diagnosis of Central Nervous System malignancy
  • Diagnosis that is a contraindication to SCS implantation or surgery
  • Diagnosis that precludes the subject from full participation in physical therapy
  • Known osteopenia/osteoporosis
  • Impairment in post-operative recovery per clinical evaluation by the principal investigator
  • Inability to participate in the protocol, including but not limited to all study visits and assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants

Baseline: participants will undergo lower extremity muscle strength testing, electromyography, spine and brain MRI, and complete a battery of questionnaires

All participants will undergo a clinically indicated spinal cord stimulator implanted for refractory chronic pain.

SCS Optimization phase consists of weekly research visits for 1 month. SCS parameters will be optimized for voluntary control of lower extremity muscles.

Individualized Neurorehabilitation phase consists of 4 x weekly visits for 5-months. With the SCS settings turned on for muscle activation, participants will undergo progressive neurorehabilitation by a spinal cord specialized physical therapist.

All participants who complete the 6-month timepoint will be invited to continue long-term follow up.
Other: Adjustment of spinal cord stimulation parameters for voluntary motor control
All patients will receive a spinal cord stimulator and undergo adjustment of stimulation parameters for optimal voluntary lower extremity motor control during research visits. Muscle strength will be assessed with the stimulation turned on and off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: 0-6 months after baseline
The primary endpoint of this study is the safety of stimulation parameters for motor function assessed with the number of adverse events for the duration of the study. Relatedness of adverse events to treatment is determined by the principal investigator.
0-6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: 1-6 months after baseline
The ability to restore previously lost voluntary motor function of the lower extremity will be measured with the Medical Research Council (MRC) grade and compared to baseline. MRC grades range from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A higher grade indicates a better outcome.
1-6 months after baseline
Neuroimaging volumetric measures
Time Frame: 0-6 months after baseline
Assessment of the functional integrity of corticospinal tracts with spine and brain Magnetic Resonance Imaging (MRI) will be performed at baseline and at the last follow up. MRI volumetric measures are quantified in mm^2.
0-6 months after baseline
Voluntary Motor Function
Time Frame: 0-6 months after baseline
Functional change assessed with the total score on the American Spinal Injury Association Impairment Scale (AIS) of each participant before spinal cord stimulation (SCS) and after SCS augmented with neurorehabilitation therapy. The AIS scale ranges from A (no sensory or motor function is preserved in sacral segments of S4-S5) to E (sensation and motor testing are normal in all segments), with A representing the worst outcome and E representing the best outcome.
0-6 months after baseline
Optimized stimulation amplitude for voluntary motor function
Time Frame: 1-6 months after baseline
Stimulation amplitude required for voluntary motor function measured in mA (miliAmperes) when supine, assisted/independent standing, stepping, walking.
1-6 months after baseline
Optimized stimulation frequency for voluntary motor function
Time Frame: 1-6 months after baseline
Stimulation frequency required for voluntary motor function measured in Hz (Hertz) when supine, assisted/independent standing, stepping, walking.
1-6 months after baseline
Optimized stimulation pulse width for voluntary motor function
Time Frame: 1-6 months after baseline
Stimulation pulse width required for voluntary motor function measured in microseconds when supine, assisted/independent standing, stepping, walking.
1-6 months after baseline
Locomotive ability
Time Frame: 1-6 months after baseline
Ability to stand, step, or walk either assisted or unassisted assessed with the Walking Index for Spinal Cord Injury II (WISCI II) scale. The WISCI II scale ranges from minimum score of 0 (unable to stand) to maximum score of 20 (ambulates with no devices, brace or assistance). A higher score represents a better outcome.
1-6 months after baseline
Serious adverse events
Time Frame: 1-6 months after baseline
Serious adverse events related to the post-SCS implant neurorehabilitation therapy.
1-6 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Study Chair: Yi Lu, MD, PhD, Brigham and Women's Hospital/Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared other than published de-identified data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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