Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI

NCT ID: NCT05333770

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High-frequency repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gail F Forrest, Ph.D.

Role: CONTACT

973-324-3518

Facility Contacts

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Gail F Forrest, Ph.D.

Role: primary

973-324-3518

Other Identifiers

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R-1107-20

Identifier Type: -

Identifier Source: org_study_id

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