Using rTMS to improve motor function after spinal cord injury
Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
NA · Oslo University Hospital · NCT06464744
This study is testing if a new type of brain stimulation can help people with spinal cord injuries improve their movement and reduce pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06464744 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) on patients with spinal cord injuries to enhance motor function. A total of 20 patients with low cervical or thoracic spinal cord injuries will be randomly assigned to receive either active rTMS or a placebo stimulation. The treatment involves 15 sessions of theta burst stimulation over three weeks, followed by a 12-week follow-up to assess improvements in motor function and pain levels. The goal is to determine the clinical relevance of rTMS for rehabilitation in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic incomplete cervical or thoracic spinal cord injuries classified as ASIA C or D.
Not a fit: Patients with contraindications to rTMS, such as severe head trauma or active epilepsy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve motor function and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown promise in using rTMS for motor function rehabilitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years and less than 80 years * Chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., C4-T12 and classified as ASIA C or D) (Figure 138). * Capable and willing to provide informed consent and able to adhere to the treatment schedule * Patients who can be followed for the whole duration of the study 6.3 Exclusion criteria * Contraindication to rTMS: * past severe head trauma * history of epilepsy or ongoing epilepsy * active cerebral tumor * intracranial hypertension * implanted ferromagnetic devices such as cardiac pacemaker and neurostimulator and cochlear implants * pregnancy or lactation. * Any clinically significant or unstable medical or psychiatric disorder * Other ongoing research protocol or recent past protocol within two months before the inclusion * History of treatment with Deep Brain Stimulation (DBS) * Subjects protected by law (guardianship or tutelage measure) * History of substance abuse (alcohol, drugs) * Pending litigation * Impossibility to understand the protocol or to fill out the forms * Chronic use of sedative medication * Participation in another clinical trial evaluating spinal cord injury
Where this trial is running
Oslo
- Oslo University Hospital - Rikshospitalet — Oslo, Norway (RECRUITING)
Study contacts
- Study coordinator: Mark Züchner, MD, PhD
- Email: mark.zuchner@medisin.uio.no
- Phone: +47 23070000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Myelopathy, rTMS, rehabilitation, spinal cord injury, motor cortex stimulation