Overview

This trial is active, not recruiting.

Condition spinal cord injuries
Treatment transcranial magnetic stimulation using itbs paradigm
Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Start date January 2016
End date September 2016
Trial size 12 participants
Trial identifier NCT02914418, STH18997

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(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.
transcranial magnetic stimulation using itbs paradigm repetitive Transcranial Magnetic Stimulation
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.
(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.
transcranial magnetic stimulation using itbs paradigm repetitive Transcranial Magnetic Stimulation
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.

Primary Outcomes

Measure
Feasibility Criteria 1: Number of participants recruited
time frame: Through to study completion, up to 6 months
Feasibility Criteria 2: Number of participants completing intervention protocol
time frame: Through to study completion, up to 6 months
Feasibility Criteria 3: Number of Valid data sets
time frame: Through to study completion, up to 6 months
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
time frame: Through to study completion, up to 6 months

Secondary Outcomes

Measure
Modified Ashworth Scale (MAS)
time frame: Baseline and 2 weeks
Range of Motion (RoM)
time frame: Baseline and 2 weeks
Leeds Arm Spasticity Impact Scale (LASIS)
time frame: Baseline and 2 weeks
Visual Analogue Scale (Spasticity) (VAS-S)
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)
time frame: Baseline and 2 weeks
Spinal Cord Independence Measure (SCIM) - Version 3
time frame: Baseline and 2 weeks
Visual Analogue Scale (Pain) - (VAS-P)
time frame: Baseline and 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Feasibility Study to Investigate the Effects of Transcranial Magnetic Stimulation (TMS) Using Theta Burst Stimulation (TBS) to Treat Upper Limb Dysfunction and Spasticity in Patients With Spinal Cord Injury
Principal investigator Ali Gharooni
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Sheffield Teaching Hospitals NHS Foundation Trust.