Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464744
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-05
Brief Title:
Efficacy of rTMS Treatment After Spinal Cord Injury
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury A Placebo-controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation rTMS of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury This study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functionsThe results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury The outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment
Detailed Description:
The investigators will recruit 20 patients with low cervical or thoracic ASIA C or D spinal cord injuries based on specific inclusion and exclusion criteria The patients will be randomized into 2 groups Each group will receive either the theta burst stimulation or the placebo stimulation rTMS will be delivered using a figure-of-eight coil positioned on the patients head targeting the leg area of the primary motor cortex After the motor threshold MT is determined patients will receive a unilateral 90 subthreshold theta burst stimulation for 3 minutes The protocol includes 15 stimulation sessions over a 3-week period The 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally Secondary outcomes include pain using the NRS scale and self-reported evaluation of autonomic functions before during and after the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None