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Trial record 6 of 21 for:    HF-rTMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05333770
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : October 14, 2022
Information provided by (Responsible Party):
Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: High-frequency repetitive transcranial magnetic stimulation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation as a Means to Promote CST Axon Regeneration in Persons With Spinal Cord Injury
Actual Study Start Date : August 20, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Device: 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 Measures :
  1. Neuro Recovery Scale (NRS). [ Time Frame: 6 months ]
    Measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This type of scale can be administered verbally.

  2. GRASSP [ Time Frame: 6 months ]

    The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is an extensive and validated impairment and functional measure which is able to detect subtle neurologic changes in individuals with spinal cord injury.

    Specifically, it evaluates the domains of sensation, strength, quality of different grip patterns and the ability to complete a variety of functional tasks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05333770

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Contact: Gail F Forrest, Ph.D. 973-324-3518

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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Gail F Forrest, Ph.D.    973-324-3518   
Sponsors and Collaborators
Kessler Foundation
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Responsible Party: Kessler Foundation Identifier: NCT05333770    
Other Study ID Numbers: R-1107-20
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries