Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI

Spinal Cord Injuries Clinical Trial

— rTMS  

Official title:

Repetitive Transcranial Magnetic Stimulation as a Means to Promote CST Axon Regeneration in Persons With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333770
• Other study ID #: R-1107-20
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: August 2023

Study information

• Verified date: October 2022
• Source: Kessler Foundation
• Contact: Gail F Forrest, Ph.D.
• Phone: 973-324-3518
• Email: gforrest[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuro Recovery Scale (NRS).	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.	6 months
Primary	GRASSP	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.	6 months