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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation using iTBS Paradigm
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring transcranial magnetic stimulation, Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord, Spinal Cord Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Royal Spinal Injuries Centre, Northern General Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active iTBS

Sham iTBS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility Criteria 1: Number of participants recruited
Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
Feasibility Criteria 2: Number of participants completing intervention protocol
10 participants completing full intervention protocol
Feasibility Criteria 3: Number of Valid data sets
10 complete valid data sets
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
No serious adverse events

Secondary Outcome Measures

Modified Ashworth Scale (MAS)
MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.
Range of Motion (RoM)
Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.
Leeds Arm Spasticity Impact Scale (LASIS)
Questionnaire assessing impact of spasticity on a person.
Visual Analogue Scale (Spasticity) (VAS-S)
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.
American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)
A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
Spinal Cord Independence Measure (SCIM) - Version 3
scale developed to address the ability of SCI patients to perform basic activities of daily living independently.
Visual Analogue Scale (Pain) - (VAS-P)
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.

Full Information

First Posted
August 23, 2016
Last Updated
May 4, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02914418
Brief Title
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
Acronym
TUSI
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
transcranial magnetic stimulation, Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord, Spinal Cord Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active iTBS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham iTBS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation using iTBS Paradigm
Other Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility Criteria 1: Number of participants recruited
Description
Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
Time Frame
Through to study completion, up to 6 months
Title
Feasibility Criteria 2: Number of participants completing intervention protocol
Description
10 participants completing full intervention protocol
Time Frame
Through to study completion, up to 6 months
Title
Feasibility Criteria 3: Number of Valid data sets
Description
10 complete valid data sets
Time Frame
Through to study completion, up to 6 months
Title
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
Description
No serious adverse events
Time Frame
Through to study completion, up to 6 months
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.
Time Frame
Baseline and 2 weeks
Title
Range of Motion (RoM)
Description
Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.
Time Frame
Baseline and 2 weeks
Title
Leeds Arm Spasticity Impact Scale (LASIS)
Description
Questionnaire assessing impact of spasticity on a person.
Time Frame
Baseline and 2 weeks
Title
Visual Analogue Scale (Spasticity) (VAS-S)
Description
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.
Time Frame
Baseline and 2 weeks
Title
American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)
Description
A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
Time Frame
Baseline and 2 weeks
Title
Spinal Cord Independence Measure (SCIM) - Version 3
Description
scale developed to address the ability of SCI patients to perform basic activities of daily living independently.
Time Frame
Baseline and 2 weeks
Title
Visual Analogue Scale (Pain) - (VAS-P)
Description
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.
Time Frame
Baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram Hariharan, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Gharooni
Organizational Affiliation
Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Royal Spinal Injuries Centre, Northern General Hospital.
City
Sheffield
State/Province
South Yourkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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