Efficacy of rTMS Treatment After Spinal Cord Injury
Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study
Oslo University Hospital
20 participants
Jan 15, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria16
- 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
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Interventions
Intermittent Theta burst stimulation will be delivered on the on the primary motor cortex using a figure-of-eight coil, supported by neuronavigation. The stimulation intensity will be set to 90% of the motor threshold
The placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06464744