Recruiting

Repetitive TMS

Sponsor:

Kessler Foundation

Code:

NCT05333770

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

High-frequency repetitive transcranial magnetic stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05333770

Start date

Aug 20, 2022

Status verified date

Oct, 2022

Completion date

Aug, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SCI Group

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.

Interventions

High-frequency repetitive transcranial magnetic stimulation

TMS is an investigational device that provides a way to test the function of a specific part of the brain that is devoted to moving my affected upper limbs by directing a low electrical current to that part of the brain through the scalp.

Primary outcome measure

  • Neuro Recovery Scale (NRS). [ Time Frame: 6 months ]
  • GRASSP [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Gail F Forrest, Ph.D.

973-324-3518gforrest@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Gail F Forrest, Ph.D.

973-324-3518gforrest@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-10-14.