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

NCT ID: NCT02914418

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active iTBS

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.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation using iTBS Paradigm

Intervention Type: 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.

Sham iTBS

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.

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation using iTBS Paradigm

Intervention Type: 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.

Interventions

Transcranial 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.

Intervention Type: DEVICE

Other Intervention Names

repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ram Hariharan, MD

Role: STUDY_CHAIR

Sheffield Teaching Hospitals NHS Foundation Trust

Ali Gharooni

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.

Locations

Princess Royal Spinal Injuries Centre, Northern General Hospital.

Sheffield, South Yourkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH18997

Identifier Type: -

Identifier Source: org_study_id