Epidural Stimulation After Neurologic Damage

Epidural Stimulation for Spinal Cord Injury

Sponsors

Lead Sponsor: University of Minnesota

Collaborator: Minnesota Office of Higher Education
Minneapolis Veterans Affairs Medical Center
Hennepin Healthcare Research Institute
Hennepin County Medical Center, Minneapolis

Source 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.

Overall Status Recruiting
Start Date August 7, 2017
Completion Date January 2023
Primary Completion Date January 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Volitional Response Index Magnitude Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Secondary Outcome
Measure Time Frame
Change in Blood pressure (Systolic and Diastolic) Over 12 months
Cerebrovascular Assessment Change Months: 3, 6, 9
Change in Visual Neurocognitive Assessment Months: 3, 6, 9
Accelerometer investigation of Parameter Space Evaluated 1 hour of 4 days per week over 12 months
Effect of SCS on urinary control Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Epidural Spinal Cord Stimulation

Description: epidural spinal cord stimulator

Arm Group Label: Epidural Spinal Cord Stimulation

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

Gender: All

Minimum Age: 22 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
David Darrow, MD Principal Investigator University of Minnesota
Overall Contact

Last Name: Study Coordinator

Phone: 612-873-9113

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Hennepin County Medical Center David Darrow, MD MPH 612-217-4290 [email protected] David Darrow, MD MPH Principal Investigator Uzma Samadani, MD PhD Sub-Investigator
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Epidural Spinal Cord Stimulation

Type: Experimental

Description: Epidural Spinal Cord Stimulation

Acronym E-STAND
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: Masking is done during formal testing of BMCA

Source: ClinicalTrials.gov