Epidural Stimulation After Neurologic Damage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Injuries Paraplegia, Complete

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking is done during formal testing of BMCA

Study Groups

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Epidural Spinal Cord Stimulation

Group Type EXPERIMENTAL

Epidural Spinal Cord Stimulation

Intervention Type DEVICE

epidural spinal cord stimulator

Interventions

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Epidural Spinal Cord Stimulation

epidural spinal cord stimulator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No