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

NHS Foundation Trust

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Transcranial Magnetic Stimulation using iTBS Paradigm

Study type: Interventional

Funder types: Other

Identifiers

NCT02914418

STH18997

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Active iTBS

Experimental group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation using iTBS Paradigm

Sham iTBS

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation using iTBS Paradigm