Epidural Stimulation After Neurologic Damage

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Paraplegia, Complete
• Interventions: Device: Epidural Spinal Cord Stimulation

• Registration Number: NCT03026816
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Study Timeline

• Study First Submitted: 2017-01-01
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-08-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural Spinal Cord Stimulation	Epidural Spinal Cord Stimulation	Epidural Spinal Cord Stimulation

Primary Outcome Measures

Name	Time	Method
Change in Volitional Response Index Magnitude	Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15	Brain Motor Control Assessment Volitional Response Index Magnitude

Secondary Outcome Measures

Name	Time	Method
Cerebrovascular Assessment Change	Months: 3, 6, 9	Cerebral blood flow (CBF) during tilt table
Spinal cord stimulation optimization	Over 12 months	Probit preference response surface obtained by serial force binary choice
Spinal cord stimulation for cardiovascular function	Over 12 months	Systolic blood pressure measured during epidural stimulation (continuous)
Change in Visual Neurocognitive Assessment	Months: 3, 6, 9	Stroop Test

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States