Recruiting

Cervical & Brain Stimulation

Sponsor:

Jason Carmel

Code:

NCT06867809

Conditions

Spinal Cord Injury

Spinal Cord Injury Cervical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epidural spinal cord stimulation and paired spine and brain stimulation

Study Details

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

Study ID

NCT06867809

Start date

Jan 15, 2026

Status verified date

Oct, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidural Spinal Cord Stimulation

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.

Interventions

Epidural spinal cord stimulation and paired spine and brain stimulation

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).

Primary outcome measure

  • Serious adverse events related to the study device [ Time Frame: From enrollment to the end of follow up at 30 weeks ]
  • 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 ]

Central Contacts and Locations

Central contacts

Evan F. Joiner, MD

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

Emelly Carrasco

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

Locations

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

Recruiting

New York, New York, United States, 10032

Contacts

Evan F Joiner, MD

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

Emelly Carrasco

212-305-2700ec3267@cumc.columbia.edu

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

Recruiting

New York, New York, United States, 10034

Contacts

Evan F Joiner, MD

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

Emelly Carrasco

212-305-2700ec3267@cumc.columbia.edu

More Information

Sponsor

Jason Carmel

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Spinal Cord Injury
  • Spinal Cord Stimulation
  • Neurorehabilitation
  • Neurological Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jason Carmel on 2025-10-30.