Clinical trial NCT06438991: Spinal Cord Stimulation for Lower Extremity Function
Official title: Epidural Spinal Cord Stimulation for Lower Extremity Motor Function in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: epidural spinal cord stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: 0-6 months after baseline
Secondary outcomes:
measure: Muscle Strength
timeFrame: 1-6 months after baseline
measure: Neuroimaging volumetric measures
timeFrame: 0-6 months after baseline
measure: Voluntary Motor Function
timeFrame: 0-6 months after baseline
measure: Optimized stimulation amplitude for voluntary motor function
timeFrame: 1-6 months after baseline
measure: Optimized stimulation frequency for voluntary motor function
timeFrame: 1-6 months after baseline
measure: Optimized stimulation pulse width for voluntary motor function
timeFrame: 1-6 months after baseline
measure: Locomotive ability
timeFrame: 1-6 months after baseline
measure: Serious adverse events
timeFrame: 1-6 months after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Yi Lu, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.