Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJason Carmel
About this trial
Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury. While some scientists have begun to study the effect of electrical stimulation on patient's ability to walk and move their legs after lower spinal cord injury, the use of stimulation of the upper (cervical) spine to restore arm and hand function after cervical spinal cord injury remains less well explored. The investigators are doing this research study to improve understanding of whether cervical spinal cord stimulation and brain stimulation can be used to improve arm and hand function. To do this, the investigators will combine spine stimulation (in the form of electrical stimulation from electrical stimulation wires temporarily implanted next to the cervical spinal cord) and brain stimulation (in the form of transcranial magnetic stimulation). The investigators will perform a series of experiments over 29 days to study whether these forms of stimulation can be applied and combined to provide improvement in arm and hand function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years with incomplete traumatic SCI (American Spinal Injury Association (ASIA) B-D, levels between C4 to T1) incurred > 1 year before the start of the study
At least 2/5 motor power in at least one upper extremity muscle group
International Standards for Neurological Classification of Spinal Cord Injury Upper Extremity Motor Score (ISNCSCI-UEMS) ≤ 40/50
Able to follow multistep commands
Disqualifiers
Cervical or thoracic stenosis that would preclude safe lead placement
Any ongoing ventilator use (continuous or intermittent)
Urinary tract infection or pneumonia requiring treatment (within past 3 months)
Skin ulcers or other lesions
Trial design
Design model
Single group
Treatments tested in this trial
Epidural spinal cord stimulation and paired spine and brain stimulation
DeviceThe spinal cord and brain stimulator allows for stimulation of the spinal cord and brain. Spinal cord stimulation (SCS) is provided by temporarily implanted SCS catheter electrode leads (Medtronic) that are connected to an external stimulator (Digitimer); brain stimulation is provided by transcranial magnetic stimulation (TMS).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Epidural Spinal Cord StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious adverse events related to the study device
To assess safety of spinal cord stimulation and paired spine and brain stimulation for movement recovery after spinal cord injury, the investigators will record the number of serious adverse events related to the study device.
Time frame
From enrollment to the end of follow up at 30 weeks2
Cessation of spinal cord stimulation or brain stimulation due to participant request
To assess tolerability of spinal cord and brain stimulation for movement recovery after spinal cord injury, the investigators will record the number of instances a participant requests permanent cessation of stimulation.
Time frame
From enrollment to the end of follow up at 30 weeksSecondary outcomes
1
Efficacy derived from spine-only and brain-only recruitment curves
Efficacy of stimulation is calculated as 1/threshold for provoking an motor evoked potentials. The threshold will be calculated from the spine-only and brain-recruitment curves. It is measured in units of 1/mA.
Time frame
Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)2
Selectivity derived from spine-only and brain-only recruitment curves
Selectivity of stimulation is calculated from the recruitment curves of the target muscle compared to non-targeted muscles. Selectivity is unitless.
Time frame
Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)3
Immediate effect of volitional motor activation combined with spinal stimulation
Immediate effect of volitional motor activation combined with spinal stimulation will be defined as the area under the curve (AUC) of the motor evoked potential (MEP) generated by attempted volitional activation optimally integrated with SCS divided by the sum of MEPs generated by attempted volitional activation at 10%-20% maximum effort alone and SCS alone. The immediate effect is unitless.
Time frame
Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)4
Immediate pairing effect of spine and brain stimulation
Immediate pairing effect of spine and brain stimulation will be defined as the area under the curve (AUC) of the motor evoked potential (MEP) generated by optimally paired spine and brain stimulation divided by the sum of MEPs generated by SCS and TMS alone. Immediate pairing effect is unitless.
Time frame
Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jason Carmel
Lead sponsor
Columbia University
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov