This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for \~200sec and can promote changes in neural activity.
Princess Royal Spinal Injuries Centre, Northern General Hospital.
Sheffield, South Yourkshire, United Kingdom
Feasibility Criteria 1: Number of participants recruited
Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
Time frame: Through to study completion, up to 6 months
Feasibility Criteria 2: Number of participants completing intervention protocol
10 participants completing full intervention protocol
Time frame: Through to study completion, up to 6 months
Feasibility Criteria 3: Number of Valid data sets
10 complete valid data sets
Time frame: Through to study completion, up to 6 months
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
No serious adverse events
Time frame: Through to study completion, up to 6 months
Modified Ashworth Scale (MAS)
MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.
Time frame: Baseline and 2 weeks
Range of Motion (RoM)
Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.
Time frame: Baseline and 2 weeks
Leeds Arm Spasticity Impact Scale (LASIS)
Questionnaire assessing impact of spasticity on a person.
Time frame: Baseline and 2 weeks
Visual Analogue Scale (Spasticity) (VAS-S)
A 100mm line with two statements at each end (No spasticity, worst spasticity). The patient will mark on the line their own perception of how bad they feel their spasticity is.
Time frame: Baseline and 2 weeks
American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)
A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
Time frame: Baseline and 2 weeks
Spinal Cord Independence Measure (SCIM) - Version 3
scale developed to address the ability of SCI patients to perform basic activities of daily living independently.
Time frame: Baseline and 2 weeks
Visual Analogue Scale (Pain) - (VAS-P)
A 100mm line with two statements at each end (no pain, worst pain). The patient will mark on the line their own perception of how bad they feel their pain is.
Time frame: Baseline and 2 weeks
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