Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT02914418
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-08-23
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Princess Royal Spinal Injuries Centre, Northern General Hospital.; 🇬🇧 Sheffield, South Yourkshire, United Kingdom