Spinal Cord Stimulation for Lower Extremity Function

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Incidence of treatment-related adverse events [Time frame: 0-6 months after baseline]

Secondary outcome measures (8)

• Muscle Strength [Time frame: 1-6 months after baseline]
• Neuroimaging volumetric measures [Time frame: 0-6 months after baseline]
• Voluntary Motor Function [Time frame: 0-6 months after baseline]
• Optimized stimulation amplitude for voluntary motor function [Time frame: 1-6 months after baseline]
• Optimized stimulation frequency for voluntary motor function [Time frame: 1-6 months after baseline]
• Optimized stimulation pulse width for voluntary motor function [Time frame: 1-6 months after baseline]
• Locomotive ability [Time frame: 1-6 months after baseline]
• Serious adverse events [Time frame: 1-6 months after baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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 PMID 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. PMID 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.20 PMID 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. PMID 30667299

Identifiers

NCT: NCT06438991 · 2024P000184

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗