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

NCT02914418 | Completed

• 1 other identifier: STH18997
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial magnetic stimulation; Spinal Cord Injuries; Muscle Spasticity; Pain; Spinal Cord; Spinal Cord Diseases

Outcome Measures

Primary Outcomes (4)

• Feasibility Criteria 1: Number of participants recruited

  Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)

  Through to study completion, up to 6 months

• Feasibility Criteria 2: Number of participants completing intervention protocol

  10 participants completing full intervention protocol

  Through to study completion, up to 6 months

• Feasibility Criteria 3: Number of Valid data sets

  10 complete valid data sets

  Through to study completion, up to 6 months

• Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants

  No serious adverse events

  Through to study completion, up to 6 months

Secondary Outcomes (7)

• Modified Ashworth Scale (MAS)

  Baseline and 2 weeks

• Range of Motion (RoM)

  Baseline and 2 weeks

• Leeds Arm Spasticity Impact Scale (LASIS)

  Baseline and 2 weeks

• Visual Analogue Scale (Spasticity) (VAS-S)

  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)

  Baseline and 2 weeks

Study Arms (2)

Active iTBS

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.

Device: Transcranial Magnetic Stimulation using iTBS Paradigm

Sham iTBS

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.

Device: Transcranial Magnetic Stimulation using iTBS Paradigm

Interventions

Transcranial Magnetic Stimulation using iTBS Paradigm 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.

Also known as: repetitive Transcranial Magnetic Stimulation

Active iTBS; Sham iTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Princess Royal Spinal Injuries Centre, Northern General Hospital.

Sheffield, South Yourkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity; Pain; Spinal Cord Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Ram Hariharan, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

• Ali Gharooni

  Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 26, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

GB (1)