Spinal Cord InjuryNCT06867809
Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury
A study testing Epidural spinal cord stimulation and paired spine and brain stimulation in people with Spinal Cord Injury and Spinal Cord Injury Cervical, run by Jason Carmel at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Spinal Cord Injury Cervical
- What is being tested?
- Epidural spinal cord stimulation and paired spine and brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ability and willingness to provide informed consent
- English speaking
Who cannot join
- 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
- History of posterior cervical fusion
- Autonomic dysreflexia requiring treatment (within past 3 months)
Show all 24Show fewer
- Implanted brain stimulators
- Intracranial aneurysm clips
- Ferromagnetic metallic implants in the head (except for within mouth)
- Any active implanted device including intrathecal medication pumps or existing spinal cord stimulators (does not include non-active spinal instrumentation such as rods, screws, or interbody devices)
- Cochlear implants
- Cardiac pacemaker/defibrillator
- Any history of seizures
- Family history of idiopathic epilepsy in a first degree relative
- Bipolar disorder
- Any history of suicide attempt
- Active psychosis
- Intracranial lesion or increased intracranial pressure
- History of stroke or intracranial neurologic conditions with structural damage
- Medications that lower seizure threshold
- Substance use that lowers seizure threshold (heavy alcohol use)
- Moderate to severe heart disease
- Pregnancy or plans to become pregnant within the study period
- Any other medical or psychological condition that precludes involvement in the study as determined by a study physician
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NewYork-Presbyterian Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New York, 10032
Evan F Joiner, MD, 212-305-2700 ext. 3, efj2107@cumc.columbia.edu
Emelly Carrasco, 212-305-2700 ext. 3, ec3267@cumc.columbia.edu
- Recruiting
NewYork-Presbyterian Allen Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)
New York, New York, 10034
Evan F Joiner, MD, 212-305-2700 ext. 3, efj2107@cumc.columbia.edu
Emelly Carrasco, 212-305-2700 ext. 3, ec3267@cumc.columbia.edu
About this study
Official title: Pilot Study to Evaluate the Safety and Tolerability of Spinal Cord Stimulation (SCS) and Paired Spine And Brain Stimulation For Movement Recovery After Spinal Cord Injury (SCI)
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.
Read the detailed description
Loss of movement following spinal cord injury (SCI) often results from incomplete disruption of structures within the spinal cord, leaving some residual pathways of communication intact. Epidural spinal cord stimulation (SCS) has been used to recruit these residual communication pathways' spared circuits and restore walking in patients with leg paralysis. But SCS to improve arm and hand function remains largely unexplored, even though this is the commonest type of SCI and restoration of upper limb function is of highest priority to patients. The goal of this study is to understand the interactions between SCS and residual neural communication pathways in the brain and spine that control arm and hand function in order to restore movement after cervical SCI.
This is a pilot study in which patients with traumatic spinal cord injury will undergo temporary placement of small electronic stimulation wires near the cervical spinal cord followed by a series of experiments over 29 days focused on three main aims. In Aim 1 (mapping responses to SCS), the investigators will map patient's motor responses to SCS to identify how motor responses are affected by areas of spinal cord injury. In Aim 2 (pairing SCS with attempted motor activation and brain stimulation), the investigators will combine SCS with patient attempts to move in order to study how SCS interacts with conscious motor control and also pair SCS with brain stimulation using transcranial magnetic stimulation. Finally, in Aim 3 (therapeutic effects), the investigators seek to use SCS to change the natural electrical circuits in the spinal cord and observe changes in motor function in both the short- and long-term.
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Cervical
- Being tested
- Epidural spinal cord stimulation and paired spine and brain stimulation
- Keywords
- Spinal Cord Injury, Spinal Cord Stimulation, Neurorehabilitation, Neurological Recovery
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural spinal cord stimulation and paired spine and brain stimulationDevice
The 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).
| Study group | Role | What they receive |
|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Participants will undergo temporary placement of cervical epidural spinal cord stimulation (SCS) electrodes. They will undergo 2 visits of stimulation optimization based on mapping of motor responses to SCS and clinical assessments at a range of SCS parameters. Once a stimulation plan has been established, subjects will undergo baseline assessments with and without SCS over 2 visits. Subjects will then undergo 15 days of continuous SCS in conjunction with structured rehabilitation with occupational therapy. On each day of therapeutic stimulation, subjects will receive two sessions of SCS plus structured rehabilitation (for up to 1.5 hours per session). Subjects will undergo a clinical assessment with and without stimulation at the midpoint of the therapeutic stimulation period. After this therapeutic stimulation period, subjects will undergo 2 days of repeat assessments. Receives: Device: Epidural spinal cord stimulation and paired spine and brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow up at 30 weeks
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.
Measured: From enrollment to the end of follow up at 30 weeks
Secondary outcomes (28)
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.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
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.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
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.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
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.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Lasting effects of sustained spine and brain pairing
To analyze the effects of sustained pairing (facilitation of muscle responses to spine and/or brain stimulation following sustained pairing), the AUC of target muscle MEPs generated from spine-only and brain-only stimulation will be compared before sustained pairing, immediately after, and every 15 minutes for up to an hour. AUC of the MEP is measured in microVolt-seconds.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Magnitude of motor evoked potentials in TMS maps
Magnitude of motor evoked potentials (MEPs) are calculated as the area under the curve of the MEP. The unit of the AUC of the MEP is microVolt-seconds. These values are then weighted across the area of responsive cortex. The final unit of measure is microVolt-seconds-cm^2.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Size of responsive cortex in TMS maps
The size of the responsive cortex will be measured as an area of responsive cortex. The unit of measure is cm^2.
Measured: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Power of cortical field potentials from EEG
Power of cortical field potentials will be calculated from EEG using the Hilbert transform. The units of power are micro-Volts-squared per Hz.
Measured: Compared with and without stimulation at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Canadian Occupational Performance Measure (COPM)- Task Importance
The COPM is a standard subjective assessment in occupational therapy. In this assessment, participants identify a list of daily tasks (including in areas of self-care, leisure, etc) that are important to them, rank the importance of that task to them (1-10, 10 being most important).
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Canadian Occupational Performance Measure (COPM)- Self-perception of performance
The COPM is a standard subjective assessment in occupational therapy. In this assessment, participants identify a list of daily tasks (including in areas of self-care, leisure, etc) that are important to them, rank their self-perception of their performance of that task (1-10, 10 being best performance).
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Canadian Occupational Performance Measure (COPM)- Self-perception of satisfaction
The COPM is a standard subjective assessment in occupational therapy. In this assessment, participants identify a list of daily tasks (including in areas of self-care, leisure, etc) that are important to them, then rank their self-perception of their satisfaction with their performance of that task (1-10, 10 being highest satisfaction).
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Patient Global Impression of Change
The Patient Global Impression of Change provides a broad assessment of the patient or clinician's response to a therapy. Using a 7-point Likert scale ranging from (1) very much improved to (7) very much worse, patients are asked to rate their overall status with respect to their spinal cord injury since starting the therapy in the trial. The investigators will record the numerical value of the participant's answer to the 7-point Likert scale questionnaire.
Measured: Study visit 25 (~end of week 5)
Clinician Global Impression of Change
The Clinician Global Impression of Change provides a broad assessment by the clinician of the patient's response to a therapy. Using a 7-point Likert scale ranging from (1) very much improved to (7) very much worse, clinicians are asked to rate the patient's overall status with respect to their spinal cord injury since starting the therapy in the trial. The investigators will record the numerical value of the participant's answer to the 7-point Likert scale questionnaire.
Measured: Study visit 25 (~end of week 5)
Off Target Effects Questionnaire
The Off Target Effects Questionnaire asks the participant simple yes/no questions about the impact of cervical stimulation on a number of other functions outside of arm and hand function including spasticity, bowel/bladder function, sexual function, balance, and cognition). The questionnaire also invites the participant to describe any changes in each of these functions in free text form. Participants will record the yes/no and narrative answers to the questionnaire. The investigators will record and report the number of participants who complete the questionnaire.
Measured: Study visit 25 (~end of week 5)
Patient-specific Daily Activity Assessment
The Patient-specific Daily Activity Assessment is an outcome measure that will be developed individually for each participant based on their specific goals for recovery. Despite the variability across participants in specific content of this outcome measure, each one will be a quantitative metric of patient performance (e.g. for a participant who wishes to improve their time required to transfer out of a wheelchair, this assessment may be "time required to transfer from wheelchair to chair"). Percentage change in this outcome measure will be reported for each participant for the sake of comparison across individuals.
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Grasp force
Grasp force will be measured with a manual dynamometer and reported in Newtons.
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Pinch force
Pinch force will be measured with a manual dynamometer and reported in Newtons.
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Box and block test score
In the box and block assessment, a subject is provided with one hundred and fifty 2.5 cm-sided blocks and asked to move as many of them as possible from one compartment (i.e. box) to another within 60 seconds. The box and block test provides an assessment of reach, grasp, transport, and release as well as fine motor control, coordination, and dexterity. The investigators will report the number of blocks moved successfully from one compartment to the other in 60 seconds.
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score- Motor
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Scale (ISNCSCI-UESS) includes an assessment of motor and sensory function used to assess the severity of spinal cord injury. Motor scores characterize motor power in the bilateral upper and lower extremities (10 myotomes on each side) using the Medical Research Council (MRC) scale from grade 0 (no contraction) to grade 5 (normal). The maximum ISNCSCI motor score is 100. For motor scores, a higher score indicates better function.
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score- Sensory
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Scale (ISNCSCI-UESS) includes an assessment of motor and sensory function used to assess the severity of spinal cord injury. Sensory scores include an assessment of light touch and pinprick for each of 28 dermatome bilaterally. For both light touch and pinprick, each bilateral dermatome is scored as follows: 0 for absent sensation, 1 for altered, and 2 for normal. The maximum sensory score is 224. For sensory scores, a higher score indicates better function.
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS)
The ISNCSCI-UEMS is a subscore of the broader ISNCSCI assessment. The ISNCSCI-UEMS characterizes motor power in the bilateral upper extremities (5 myotomes on each side) using the Medical Research Council (MRC) scale from grade 0 (no contraction) to grade 5 (normal). The maximum ISNCSCI-UEMS score is 50. A higher score indicates better motor function.
Measured: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Threshold to detect passive motion (TTDPM)
Proprioceptive function with and without continuous stimulation will be assessed using the threshold to detect passive motion (TTDPM) assessment at the metacarpophalangeal joint of the index fingers and at the joint located in a dermatome that corresponds to the primary site of stimulation. This outcome measure will be reported as the angle of motion (degrees) required to detect passive motion.
Measured: Compared with and without stimulation at visit 6 (~end of week 2)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Strength
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) is a validated assessment of sensorimotor function in patients with cervical spinal cord injury. The GRASSP (version 2) will be administered by an occupational therapist certified in GRASSP assessment. The GRASSP is reported as a series of subscores: strength (0-100, with 100 representing normal function).
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Sensation
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) is a validated assessment of sensorimotor function in patients with cervical spinal cord injury. The GRASSP (version 2) will be administered by an occupational therapist certified in GRASSP assessment. The GRASSP is reported as a series of subscores: sensation (0-24, with 24 representing normal sensation).
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Prehension Ability
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) is a validated assessment of sensorimotor function in patients with cervical spinal cord injury. The GRASSP (version 2) will be administered by an occupational therapist certified in GRASSP assessment. The GRASSP is reported as a series of subscores: prehension ability (0-24, with 24 representing normal function).
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Prehension Performance
The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) is a validated assessment of sensorimotor function in patients with cervical spinal cord injury. The GRASSP (version 2) will be administered by an occupational therapist certified in GRASSP assessment. The GRASSP is reported as a series of subscores: prehension performance (0-40, with 40 representing normal prehension performance).
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Capabilities of Upper Extremity Test (CUE-T)
The Capabilities of Upper Extremity Test (CUE-T) is a validated assessment of sensorimotor function in patients with cervical spinal cord injury. The CUE-T will be administered by an occupational therapist certified in CUE-T assessment. The maximum CUE-T score is 124, with a higher score representing greater upper extremity function and a lower score representing greater limitations in upper extremity function.
Measured: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Portion of study visits completed
The investigators will record the portion of study visits completed and report this value as a percentage of total planned visits.
Measured: From enrollment to the end of follow up at 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Jan 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Carmel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Carmel, Columbia University
- Investigators
- Jason B. Carmel, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867809
- Sponsor's protocol ID
- AAAV3409
- Other IDs
- 5UE5NS070697-15
- Status last verified
- Oct 2025
- First submitted
- 27 Feb 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Safety and Tolerability of Spinal Cord Stimulation (SCS) and Paired Spine And Brain Stimulation For Movement Recovery After Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT06867809
- Acronym / sponsor ID
- AAAV3409
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Cervical
- Keywords
- Spinal Cord Injury, Spinal Cord Stimulation, Neurorehabilitation, Neurological Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jason CarmelUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Loss of movement following spinal cord injury (SCI) often results from incomplete disruption of structures within the spinal cord, leaving some residual pathways of communication intact. Epidural spinal cord stimulation (SCS) has been used to recruit these residual communication pathways' spared circuits and restore walking in patients with leg paralysis. But SCS to improve arm and hand function remains largely unexplored, even though this is the commonest type of SCI and restoration of upper limb function is of highest priority to patients. The goal of this study is to understand the interactions between SCS and residual neural communication pathways in the brain and spine that control arm and hand function in order to restore movement after cervical SCI.
This is a pilot study in which patients with traumatic spinal cord injury will undergo temporary placement of small electronic stimulation wires near the cervical spinal cord followed by a series of experiments over 29 days focused on three main aims. In Aim 1 (mapping responses to SCS), the investigators will map patient's motor responses to SCS to identify how motor responses are affected by areas of spinal cord injury. In Aim 2 (pairing SCS with attempted motor activation and brain stimulation), the investigators will combine SCS with patient attempts to move in order to study how SCS interacts with conscious motor control and also pair SCS with brain stimulation using transcranial magnetic stimulation. Finally, in Aim 3 (therapeutic effects), the investigators seek to use SCS to change the natural electrical circuits in the spinal cord and observe changes in motor function in both the short- and long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Spinal Cord Stimulation | Experimental | Device: Epidural spinal cord stimulation and paired spine and brain stimulationParticipants will undergo temporary placement of cervical epidural spinal cord stimulation (SCS) electrodes. They will undergo 2 visits of stimulation optimization based on mapping of motor responses to SCS and clinical assessments at a range of SCS parameters. Once a stimulation plan has been established, subjects will undergo baseline assessments with and without SCS over 2 visits. Subjects will then undergo 15 days of continuous SCS in conjunction with structured rehabilitation with occupational therapy. On each day of therapeutic stimulation, subjects will receive two sessions of SCS plus structured rehabilitation (for up to 1.5 hours per session). Subjects will undergo a clinical assessment with and without stimulation at the midpoint of the therapeutic stimulation period. After this therapeutic stimulation period, subjects will undergo 2 days of repeat assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Ability and willingness to provide informed consent
Key exclusion criteria (24 listed)
- 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
- History of posterior cervical fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural spinal cord stimulation and paired spine and brain stimulationThe 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). | Device | Epidural Spinal Cord Stimulation |
Primary outcome
Serious adverse events related to the study device
Time frame: From enrollment to the end of follow up at 30 weeks
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.
Cessation of spinal cord stimulation or brain stimulation due to participant request
Time frame: From enrollment to the end of follow up at 30 weeks
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.
28 secondary outcomes
Efficacy derived from spine-only and brain-only recruitment curves
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Selectivity derived from spine-only and brain-only recruitment curves
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Immediate effect of volitional motor activation combined with spinal stimulation
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Immediate pairing effect of spine and brain stimulation
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Lasting effects of sustained spine and brain pairing
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Magnitude of motor evoked potentials in TMS maps
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Size of responsive cortex in TMS maps
Time frame: Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Power of cortical field potentials from EEG
Time frame: Compared with and without stimulation at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)
Canadian Occupational Performance Measure (COPM)- Task Importance
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Canadian Occupational Performance Measure (COPM)- Self-perception of performance
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Canadian Occupational Performance Measure (COPM)- Self-perception of satisfaction
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Patient Global Impression of Change
Time frame: Study visit 25 (~end of week 5)
Clinician Global Impression of Change
Time frame: Study visit 25 (~end of week 5)
Off Target Effects Questionnaire
Time frame: Study visit 25 (~end of week 5)
Patient-specific Daily Activity Assessment
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Grasp force
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Pinch force
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Box and block test score
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score- Motor
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score- Sensory
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS)
Time frame: Compared with and without stimulation at visits 7/8, 16, and 24/25 (~end of week 2, beginning of week 4, and end of week 5)
Threshold to detect passive motion (TTDPM)
Time frame: Compared with and without stimulation at visit 6 (~end of week 2)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Strength
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Sensation
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Prehension Ability
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)- Prehension Performance
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Compared with and without stimulation at visits 7/8 and 24/25 (~end of week 2 and end of week 5)
Portion of study visits completed
Time frame: From enrollment to the end of follow up at 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason B. Carmel, MD, PhD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural spinal cord stimulation and paired spine and brain stimulation in people with Spinal Cord Injury and Spinal Cord Injury Cervical, run by Jason Carmel at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan F. Joiner, MD (212-305-2700 ext. 3, efj2107@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events related to the study device (time frame: From enrollment to the end of follow up at 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.