Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06867809

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

Led by Jason Carmel · Updated on 2025-10-30

20

Participants Needed

2

Research Sites

62 weeks

Total Duration

On this page

Sponsors

J

Jason Carmel

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 6518 years with incomplete traumatic spinal cord injury at levels between C4 to T1 incurred more than 1 year before the study
  • At least 2/5 motor power in at least one upper extremity muscle group
  • Upper Extremity Motor Score (ISNCSCI-UEMS) of 40/50 or less
  • Ability to follow multistep commands
  • Ability and willingness to provide informed consent
  • English speaking
Not Eligible

You will not qualify if you...

  • Cervical or thoracic stenosis preventing safe lead placement
  • Any ongoing continuous or intermittent ventilator use
  • Urinary tract infection or pneumonia needing treatment within the past 3 months
  • Skin ulcers or other skin 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 inside the mouth)
  • Any active implanted device including intrathecal medication pumps or spinal cord stimulators (non-active spinal hardware allowed)
  • Cochlear implants
  • Cardiac pacemaker or 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 or substance use that lower seizure threshold (including heavy alcohol use)
  • Moderate to severe heart disease
  • Pregnancy or plans to become pregnant during the study period
  • Any other medical or psychological condition that prevents study participation as judged by a physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

New York, New York, United States, 10032

Actively Recruiting

2

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

New York, New York, United States, 10034

Actively Recruiting

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Research Team

E

Evan F. Joiner, MD

CONTACT

E

Emelly Carrasco

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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