Efficacy of rTMS Treatment After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOslo University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
past severe head trauma
history of epilepsy or ongoing epilepsy
active cerebral tumor
intracranial hypertension
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive transcranial magnetic stimulation (rTMS)
Procedure/SurgeryIntermittent 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
Placebo stimulation using a placebo coil
Procedure/SurgeryThe placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Placebo stimulationPlacebo comparator 1 intervention
Group B: Active stimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Motor evoked potentials
Motor evoked potentials will be recorded at the start and the end of each stimulation session.
Time frame
From enrollment to the end of follow up at 12 weeks2
Global spasticity
Spasticity will be evaluated by using the modified Ashworth scale from 0 (no spasticity) to 4 (rigid extremities).
Time frame
From enrollment to the end of follow-up at 12 weeks3
Spasticity lower extremities
The Wartenberg pendulum is an objective test to assess the biomechanical properties of spasticity.The test consists of dropping the leg of a relaxed patient from a horizontal position and measuring oscillatory movements with a goniometer.
Time frame
From enrollment to the end of follow-up at 12 weeks4
Nine-Hole Peg Test
The Nine-Hole Peg Test is used to measure manual dexterity in patients with various neurological diagnoses. It is described in the literature to explore upper extremity function. Patients are asked to take nine pegs (7 mm diameter, 32 mm length) from a container (square box measuring 100 x 100 x 10 mm), one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
Time frame
From enrollment to the end of follow-up at 12 weeksSecondary outcomes
1
Numeric scale rating for pain evaluation
The analgesic efficacy of the stimulation protocol will be measured by the numeric scale rating (NRS), a self-reported measure in which patients rate their pain on a scale from 0 (no pain) to 10 (worst pain).
Time frame
From enrollment to the end of follow-up at 12 weeks2
European myelopathy score
The European myelopathy score is a reliable tool to assess functional recovery. The score ranges from 5 to 18. Higher values indicate better neurological function (outcome).
Time frame
From enrollment to the end of follow-up at 12 weeksOther outcomes
1
Potential adverse effect
In general, rTMS is a safe method. The use of exclusion criteria and ear plugs during stimulation will reduce side effects. Potential risks or side effects of rTMS include: * Displacement of ferromagnetic device * Headache (3% in conventional rTMS studies) because of the noise generated by the stimulation * Seizures (0,16% in conventional rTMS studies) particularly in those with past epilepsy or brain surgery * Application site pain or discomfort and jaw pain
Time frame
From enrollment to the end of follow-up at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov