Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI (rTMS)

Kessler Foundation

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: High-frequency repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05333770

R-1107-20

Details and patient eligibility

About

This is a research study to evaluate the safety, efficacy and feasibility of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury.

Full description

This research study is investigating whether repetitive high-frequency transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury is safe, efficacious, and feasible. The study will take approximately 7-8 months to complete, during which 15 training sessions with HF-rTMS will be completed. Followed by 30 minutes each session of arm and hand training without HF-rTMS. The participants will complete testing after the 15 training sessions as well as 6 months following completion.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be less than 8 weeks post injury
• Must have an incomplete spinal cord injury at a neurological level of injury between the C2-C6 level and an impairment grade A, B, C, or D, according to the American Spinal Injury association (ASIA) Impairment Scale
• If an outpatient, will be at least 6 months post injury

Exclusion criteria

• Have a pacemaker
• Have metal in the skull
• Have a history of seizures, or a brain injury
• Being pregnant
• Have skin issues or open wounds
• Have severe contractures and/or spasms in my elbow/wrists as determined by study staff examination at screening
• Study staff will review medications to determine if taking any drugs that would increase risk of having a seizure while undergoing TMS. If taking such medications, will not be enrolled

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SCI Group

Experimental group

Description:

Complete testing at Baseline, Post, and 6 month follow up. Intervention includes 15 treatment sessions (3-5 times per week) with HF-rTMS \& 6 month follow-up. Following HF-rTMS, there will be 30 minutes of arm and hand training. Each session will last for approximately 60 mins. At baseline, post and 6 months, the following evaluations to evaluate safety and other related measures. These measures include a safety and pain questionnaire, spasticity measurement, a physician or clinician evaluation to determine motor and sensory neurological level of injury, hand and arm function measurement, evaluation of ability to perform everyday tasks, and measures to determine level of brain function.

Treatment:

Device: High-frequency repetitive transcranial magnetic stimulation