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

Conditions

• Spinal Cord Injury
• Spinal Cord Injury Cervical

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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).

Study Details

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.

Key Dates

Start date

Jan 15, 2026

Status verified

Oct 2025

Primary completion

Oct 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Evan F. Joiner, MD
  212-305-2700
  [email protected]
• Emelly Carrasco
  (212) 305-2700
  [email protected]

Locations (2)

Find similar trials in New York, NY

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