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NCT Number: NCT02914418

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Royal Spinal Injuries Centre, Northern General Hospital.

Sheffield, South Yourkshire, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: repetitive Transcranial Magnetic Stimulation

Primary outcomes

  1. Feasibility Criteria 1: Number of participants recruited

    Time frame: Through to study completion, up to 6 months

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

  2. Feasibility Criteria 2: Number of participants completing intervention protocol

    Time frame: Through to study completion, up to 6 months

    10 participants completing full intervention protocol

  3. Feasibility Criteria 3: Number of Valid data sets

    Time frame: Through to study completion, up to 6 months

    10 complete valid data sets

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

    Time frame: Through to study completion, up to 6 months

    No serious adverse events

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: 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.

  2. Range of Motion (RoM)

    Time frame: 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.

  3. Leeds Arm Spasticity Impact Scale (LASIS)

    Time frame: Baseline and 2 weeks

    Questionnaire assessing impact of spasticity on a person.

  4. Visual Analogue Scale (Spasticity) (VAS-S)

    Time frame: 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.

  5. 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

    A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.

  6. Spinal Cord Independence Measure (SCIM) - Version 3

    Time frame: Baseline and 2 weeks

    scale developed to address the ability of SCI patients to perform basic activities of daily living independently.

  7. Visual Analogue Scale (Pain) - (VAS-P)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study 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

Acronym: TUSI

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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