Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Minnesota
About this trial
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
22 years of age or older
Able to undergo the informed consent process
Stable spinal cord injury
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
Disqualifiers
Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
Use of botulinum toxin (Botox) injections in the previous six months
Clinically significant mental illness in the judgment of the principal investigator
Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
Trial design
Design model
Single group
Treatments tested in this trial
Epidural Spinal Cord Stimulation
DeviceStimulation of the spinal cord from the epidural space.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Volitional EMG powerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Volitional electromyography (EMG) power
The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation
Time frame
10 yearsSecondary outcomes
1
Prediction of power preferences
Prediction of power of preference models built based on evaluations of stimulation settings.
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov