Spinal Cord Stimulation for Lower Extremity Function

NCT06438991 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024P000184
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Spinal Cord Injury

Keywords

epidural spinal cord stimulation

Outcome Measures

Primary Outcomes (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.

  0-6 months after baseline

Secondary Outcomes (8)

• Muscle Strength

  1-6 months after baseline

• Neuroimaging volumetric measures

  0-6 months after baseline

• Voluntary Motor Function

  0-6 months after baseline

• Optimized stimulation amplitude for voluntary motor function

  1-6 months after baseline

• Optimized stimulation frequency for voluntary motor function

  1-6 months after baseline

Study Arms (1)

All participants

EXPERIMENTAL

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

Interventions

Adjustment of spinal cord stimulation parameters for voluntary motor control OTHER

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.

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (5)

• 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.

  PMID: 38398403 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

• 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.

  PMID: 24713270 BACKGROUND

• 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.

  PMID: 30430902 BACKGROUND

• 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.

  PMID: 30667299 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yi Lu, MD, PhD

  Brigham and Women's Hospital/Harvard Medical School

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurosurgical Trauma, Associate Professor of Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share