- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914418
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
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South Yourkshire
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Sheffield, South Yourkshire, United Kingdom, S5 7AU
- Princess Royal Spinal Injuries Centre, Northern General Hospital.
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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.
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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:
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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.
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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:
|
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
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Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
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Through to study completion, up to 6 months
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Feasibility Criteria 2: Number of participants completing intervention protocol
Time Frame: Through to study completion, up to 6 months
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10 participants completing full intervention protocol
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Through to study completion, up to 6 months
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Feasibility Criteria 3: Number of Valid data sets
Time Frame: Through to study completion, up to 6 months
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10 complete valid data sets
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Through to study completion, up to 6 months
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Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
Time Frame: Through to study completion, up to 6 months
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No serious adverse events
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Through to study completion, up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale (MAS)
Time Frame: Baseline and 2 weeks
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MAS is a clinical assessment of spasticity.
Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.
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Baseline and 2 weeks
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Range of Motion (RoM)
Time Frame: Baseline and 2 weeks
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Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.
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Baseline and 2 weeks
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Leeds Arm Spasticity Impact Scale (LASIS)
Time Frame: Baseline and 2 weeks
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Questionnaire assessing impact of spasticity on a person.
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Baseline and 2 weeks
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Visual Analogue Scale (Spasticity) (VAS-S)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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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
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A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
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Baseline and 2 weeks
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Spinal Cord Independence Measure (SCIM) - Version 3
Time Frame: Baseline and 2 weeks
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scale developed to address the ability of SCI patients to perform basic activities of daily living independently.
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Baseline and 2 weeks
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Visual Analogue Scale (Pain) - (VAS-P)
Time Frame: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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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