Actively Recruiting
Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
Led by Oslo University Hospital · Updated on 2024-06-18
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 functions.The 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.
CONDITIONS
Brief Title
Efficacy of rTMS Treatment After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
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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.
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Any clinically significant or unstable medical or psychiatric disorder
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Other ongoing research protocol or recent past protocol within two months before the inclusion
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History of treatment with Deep Brain Stimulation (DBS)
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Subjects protected by law (guardianship or tutelage measure)
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History of substance abuse (alcohol, drugs)
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Pending litigation
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Impossibility to understand the protocol or to fill out the forms
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Chronic use of sedative medication
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Participation in another clinical trial evaluating spinal cord injury
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
Research Team
M
Mark Züchner, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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