Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Intraoperative stimulation of the cervical spinal cord
Procedure/SurgeryThe surgeon will place spinal cord electrodes on the epidural surface, with stimulation sites identified using preoperative MRI. Recruitment curves will be generated by systematically increasing the stimulation intensity across various parameter combinations, including frequency, pulse count, pulse shape, and electrode-specific properties such as size, separation, and arrangement.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Arm 1 - Intraoperative ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of epidural SCS
Efficacy of stimulation is calculated as 1/threshold for provoking an motor evoked potentials. The threshold will be calculated from the recruitment curves.
Time frame
0-100 milliseconds after each stimulation event during the experiment2
Selectivity of epidural SCS
Selectivity is calculated from the recruitment curves of the target muscle compared to non-targeted muscles.
Time frame
0-100 milliseconds after each stimulation event during the experimentSponsors and contacts
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Columbia University
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov