Spine and Brain Stimulation for Movement Recovery After Cervical Spinal Cord Injury

NCT06867809 | Recruiting FDA Device

• 2 other identifiers: AAAV34095UE5NS070697-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Spinal Cord Injury; Spinal Cord Injury Cervical

Keywords

Spinal Cord Injury; Spinal Cord Stimulation; Neurorehabilitation; Neurological Recovery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of follow up at 30 weeks

Secondary Outcomes (28)

• Efficacy derived from spine-only and brain-only recruitment curves

  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

  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

  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

  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

  Compared at visit 7/8 to visit 24/25 (~end of week 2 and end of week 5)

Study Arms (1)

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.

Device: Epidural spinal cord stimulation and paired spine and brain stimulation

Interventions

Epidural spinal cord stimulation and paired spine and brain stimulation DEVICE

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).

Epidural Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Jason Carmel: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

NewYork-Presbyterian Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)

New York, New York, 10032, United States

RECRUITING

NewYork-Presbyterian Allen Hospital / Columbia University Irving Medical Center (NYPH/CUIMC)

New York, New York, 10034, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jason B. Carmel, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan F. Joiner, MD

CONTACT

212-305-2700; efj2107@cumc.columbia.edu

Emelly Carrasco

CONTACT

(212) 305-2700; ec3267@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Given that this is a single-arm, open label study, complete masking is not possible. However, to the greatest extent possible, subjects will be blinded to the stimulation-on versus stimulation-off conditions during assessments. In support of the blind, the stimulation condition will be determined by randomization, and both the subjects and the assessors will be blinded to the assignment of the stimulation condition. The stimulation-on condition will begin with a gradual ramp up of stimulation over the course of a minute as subjects are known to acclimate to the presence of stimulation relatively quickly; likewise, the stimulation-off condition will begin with the same one-minute ramp up of stimulation followed by a ramp down of stimulation to off over one minute.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 10, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)