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

May 4, 2017 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yourkshire
      • Sheffield, South Yourkshire, United Kingdom, S5 7AU
        • Princess Royal Spinal Injuries Centre, Northern General Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • repetitive Transcranial Magnetic Stimulation
Sham Comparator: 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.
Device: 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.
Other Names:
  • repetitive Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
10 participants completing full intervention protocol
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
10 complete valid data sets
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
No serious adverse events
Through to study completion, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks
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.
Baseline and 2 weeks
Leeds Arm Spasticity Impact Scale (LASIS)
Time Frame: Baseline and 2 weeks
Questionnaire assessing impact of spasticity on a person.
Baseline and 2 weeks
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.
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
A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
Baseline and 2 weeks
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.
Baseline and 2 weeks
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.
Baseline and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Study Chair: Ram Hariharan, MD, Sheffield Teaching Hospitals NHS Foundation Trust
  • Principal Investigator: Ali Gharooni, Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH18997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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