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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active iTBS | Experimental | iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. The hand representation of the primary motor cortex will targeted using a circular coil held over the vertex of skull. Intensity will be set to 80% of Resting Motor Threshold (RMT), which will be determined visually by the lowest percentage of stimulator output which can cause upper limb motor twitch in at least 5 out of 10 attempts. |
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| Sham iTBS | Sham Comparator | Sham iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. Intensity will be set at 80% RMT. Circular coil will be held over vertex of skull but angled away to ensure no neural stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation using iTBS Paradigm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Criteria 1: Number of participants recruited | Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month) | Through to study completion, up to 6 months |
| Feasibility Criteria 2: Number of participants completing intervention protocol | 10 participants completing full intervention protocol | Through to study completion, up to 6 months |
| Feasibility Criteria 3: Number of Valid data sets | 10 complete valid data sets | Through to study completion, up to 6 months |
| Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants | No serious adverse events | Through to study completion, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks |
| Range of Motion (RoM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ram Hariharan, MD | Sheffield Teaching Hospitals NHS Foundation Trust | Study Chair |
| Ali Gharooni | Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Royal Spinal Injuries Centre, Northern General Hospital. | Sheffield | South Yourkshire | S5 7AU | United Kingdom |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| D010146 | Pain |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.
| Baseline and 2 weeks |
| Leeds Arm Spasticity Impact Scale (LASIS) | Questionnaire assessing impact of spasticity on a person. | 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. | 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. | 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. | 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. | Baseline and 2 weeks |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |