Spinal Cord Injuries
Conditions
Keywords
transcranial magnetic stimulation, Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord, Spinal Cord Diseases
Brief summary
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.
Interventions
DEVICETranscranial Magnetic Stimulation using iTBS Paradigm
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.
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-70 years old inclusive * Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago) * Referred to the Sheffield Spinal Injuries Centre * Be able to provide written informed consent or verbal consent in the presence of an independent witness * Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above * Stable medical treatment for at least 1 week before and 1 week after TMS application * Stable medical condition
Exclusion criteria
* Aged less than 18 years old * Lack the mental capacity to consent * Ventilated patients with sedation * Very acute (\<3 months) SCI patients * Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy * Significant joint-related limitation of passive range of movement * Unable to attend all TMS sessions * Pregnancy * Inability to tolerate TBS * Significant upper limb contractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Criteria 1: Number of participants recruited | Through to study completion, up to 6 months | Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month) |
| Feasibility Criteria 2: Number of participants completing intervention protocol | Through to study completion, up to 6 months | 10 participants completing full intervention protocol |
| Feasibility Criteria 3: Number of Valid data sets | Through to study completion, up to 6 months | 10 complete valid data sets |
| Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants | Through to study completion, up to 6 months | No serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores) | Baseline and 2 weeks | A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs. |
| Modified Ashworth Scale (MAS) | Baseline and 2 weeks | MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed. |
| Visual Analogue Scale (Pain) - (VAS-P) | Baseline and 2 weeks | 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. |
| Spinal Cord Independence Measure (SCIM) - Version 3 | Baseline and 2 weeks | scale developed to address the ability of SCI patients to perform basic activities of daily living independently. |
| Range of Motion (RoM) | Baseline and 2 weeks | Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer. |
| Leeds Arm Spasticity Impact Scale (LASIS) | Baseline and 2 weeks | Questionnaire assessing impact of spasticity on a person. |
| Visual Analogue Scale (Spasticity) (VAS-S) | Baseline and 2 weeks | 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. |
Countries
United Kingdom
Outcome results
None listed