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Spinal Cord InjuryNCT06438991

Spinal Cord Stimulation for Lower Extremity Function

A study of Spinal Cord Injury, run by Brigham and Women's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jul 2024to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Joshua I. Chalif, MD, PhD contact

617-525-7378

jchalif@bwh.harvard.edu

Benjamin R Johnston, MD, PhD contact

617-525-7378

bjohnston2@mgb.org

About this study

Official title: 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.

Read the 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.

Being tested
Adjustment of spinal cord stimulation parameters for voluntary motor control
Keywords
epidural spinal cord stimulation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjustment of spinal cord stimulation parameters for voluntary motor controlOther

    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.

Study groups in NCT06438991
Study groupRoleWhat they receive
All participantsExperimentalBaseline: 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.
Receives: Other: Adjustment of spinal cord stimulation parameters for voluntary motor control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related adverse events

    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.

    Measured: 0-6 months after baseline

Secondary outcomes (8)

  1. Muscle Strength

    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.

    Measured: 1-6 months after baseline

  2. Neuroimaging volumetric measures

    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.

    Measured: 0-6 months after baseline

  3. Voluntary Motor Function

    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.

    Measured: 0-6 months after baseline

  4. Optimized stimulation amplitude for voluntary motor function

    Stimulation amplitude required for voluntary motor function measured in mA (miliAmperes) when supine, assisted/independent standing, stepping, walking.

    Measured: 1-6 months after baseline

  5. Optimized stimulation frequency for voluntary motor function

    Stimulation frequency required for voluntary motor function measured in Hz (Hertz) when supine, assisted/independent standing, stepping, walking.

    Measured: 1-6 months after baseline

  6. Optimized stimulation pulse width for voluntary motor function

    Stimulation pulse width required for voluntary motor function measured in microseconds when supine, assisted/independent standing, stepping, walking.

    Measured: 1-6 months after baseline

  7. Locomotive ability

    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.

    Measured: 1-6 months after baseline

  8. Serious adverse events

    Serious adverse events related to the post-SCS implant neurorehabilitation therapy.

    Measured: 1-6 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will receive a spinal cord stimulator. Muscle strength will be assessed with the stimulation turned on and off. Parameters for motor function will be assessed with the stimulation turned on and off.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06438991
Sponsor's protocol ID
2024P000184
Status last verified
May 2024
First submitted
21 May 2024
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be shared other than published de-identified data.

Publications

  • Chalif JI, Chavarro VS, Mensah E, Johnston B, Fields DP, Chalif EJ, Chiang M, Sutton O, Yong R, Trumbower R, Lu Y. Epidural Spinal Cord Stimulation for Spinal Cord Injury in Humans: A Systematic Review. J Clin Med. 2024 Feb 14;13(4):1090. doi: 10.3390/jcm13041090.

    PubMed 38398403

  • Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.

    PubMed 30382197

  • Angeli CA, Edgerton VR, Gerasimenko YP, Harkema SJ. Altering spinal cord excitability enables voluntary movements after chronic complete paralysis in humans. Brain. 2014 May;137(Pt 5):1394-409. doi: 10.1093/brain/awu038. Epub 2014 Apr 8.

    PubMed 24713270

  • Calvert JS, Grahn PJ, Strommen JA, Lavrov IA, Beck LA, Gill ML, Linde MB, Brown DA, Van Straaten MG, Veith DD, Lopez C, Sayenko DG, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. J Neurotrauma. 2019 May 1;36(9):1451-1460. doi: 10.1089/neu.2018.5921. Epub 2018 Dec 15.

    PubMed 30430902

  • Darrow D, Balser D, Netoff TI, Krassioukov A, Phillips A, Parr A, Samadani U. Epidural Spinal Cord Stimulation Facilitates Immediate Restoration of Dormant Motor and Autonomic Supraspinal Pathways after Chronic Neurologically Complete Spinal Cord Injury. J Neurotrauma. 2019 Aug 1;36(15):2325-2336. doi: 10.1089/neu.2018.6006. Epub 2019 Mar 6.

    PubMed 30667299

Questions about this trial

What is this clinical trial studying?

A study of Spinal Cord Injury, run by Brigham and Women's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joshua I. Chalif, MD, PhD (617-525-7378, jchalif@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (time frame: 0-6 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06438991, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

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