Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI
NCT ID: NCT05333770
Last Updated: 2022-10-14
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-08-20
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
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Kessler Foundation
OTHER
Responsible Party
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Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-1107-20
Identifier Type: -
Identifier Source: org_study_id
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