Epidural Stimulation After Neurologic Damage

Official title

Epidural Stimulation for Spinal Cord Injury

Overview

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Detailed description

Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability.

In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.

Interventions

• Device Epidural Spinal Cord Stimulation
  epidural spinal cord stimulator

Primary outcome measures

• Change in Volitional Response Index Magnitude [Time frame: Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15]

Secondary outcome measures (4)

• Spinal cord stimulation for cardiovascular function [Time frame: Over 12 months]
• Cerebrovascular Assessment Change [Time frame: Months: 3, 6, 9]
• Change in Visual Neurocognitive Assessment [Time frame: Months: 3, 6, 9]
• Spinal cord stimulation optimization [Time frame: Over 12 months]

Eligibility criteria

Inclusion criteria

• 22 years of age or older
• Able to undergo the informed consent/assent process
• Stable, motor-complete paraplegia
• Discrete spinal cord injury between C6 and T10
• ASIA A or B Spinal Cord Injury Classification
• Medically stable in the judgement of the principal investigator
• Intact segmental reflexes below the lesion of injury
• Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
• Willing to attend all scheduled appointments

Exclusion criteria

• Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
• Inability to withhold antiplatelet/anticoagulation agents perioperatively
• Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or >200.
• Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
• Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
• Clinically significant mental illness in the judgement of the principal investigator
• Botulinum toxin injections in the previous 6 months
• Volitional movements present during EMG testing in bilateral lower extremities
• Unhealed spinal fracture
• Presence of significant contracture
• Presence of pressure ulcers
• Recurrent urinary tract infection refractory to antibiotics
• Current Pregnancy

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

Treatment

Study locations

United States · 1 center

• Hennepin County Medical Center — Minneapolis

Publications

• Shackleton C, Samejima S, Miller T, Sachdeva R, Parr A, Samadani U, Netoff T, Hocaloski S, Elliott S, Walter M, Darrow D, Krassioukov A. Effect of epidural spinal cord stimulation on female sexual function after spinal cord injury. Front Neurosci. 2023 Apr 5;17:1155796. doi: 10.3389/fnins.2023.1155796. eCollection 2023. PMID 37179555
• Hoover C, Schuerger W, Balser D, McCracken P, Murray TA, Morse L, Parr A, Samadani U, Netoff TI, Darrow DP. Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. J Neurotrauma. 2024 May;41(9-10):1163-1171. doi: 10.1089/neu.2022.0322. Epub 2023 Mar 22. PMID 36719784
• Hoglund BK, Zurn CA, Madden LR, Hoover C, Slopsema JP, Balser D, Parr A, Samadani U, Johnson MD, Netoff TI, Darrow DP. Mapping Spinal Cord Stimulation-Evoked Muscle Responses in Patients With Chronic Spinal Cord Injury. Neuromodulation. 2023 Oct;26(7):1371-1380. doi: 10.1016/j.neurom.2022.10.058. Epub 2022 Dec 12. PMID 36517395
• Darrow DP, Balser DY, Freeman D, Pelrine E, Krassioukov A, Phillips A, Netoff T, Parr A, Samadani U. Effect of epidural spinal cord stimulation after chronic spinal cord injury on volitional movement and cardiovascular function: study protocol for the phase II open label controlled E-STAND trial. BMJ Open. 2022 Jul 18;12(7):e059126. doi: 10.1136/bmjopen-2021-059126. PMID 35851008
• Pena Pino I, Hoover C, Venkatesh S, Ahmadi A, Sturtevant D, Patrick N, Freeman D, Parr A, Samadani U, Balser D, Krassioukov A, Phillips A, Netoff TI, Darrow D. Long-Term Spinal Cord Stimulation After Chronic Complete Spinal Cord Injury Enables Volitional Movement in the Absence of Stimulation. Front Syst Neurosci. 2020 Jun 30;14:35. doi: 10.3389/fnsys.2020.00035. eCollection 2020. PMID 32714156

Identifiers

NCT: NCT03026816 · NEUROSURG-2017-25478

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗