Spinal Cord InjuriesTUSINCT02914418
Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
A study testing Transcranial Magnetic Stimulation using iTBS Paradigm in people with Spinal Cord Injuries, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcranial Magnetic Stimulation using iTBS Paradigm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Unable to attend all TMS sessions
- Pregnancy
- Inability to tolerate TBS
- Significant upper limb contractures
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Princess Royal Spinal Injuries Centre, Northern General Hospital.
Sheffield, South Yourkshire, S5 7AU
About this study
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
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
- Being tested
- Transcranial Magnetic Stimulation using iTBS Paradigm
- Keywords
- transcranial magnetic stimulation, Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord, Spinal Cord Diseases
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation using iTBS ParadigmDevice
Also called repetitive Transcranial Magnetic Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Magnetic Stimulation using iTBS Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Criteria 1: Number of participants recruited
Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)
Measured: Through to study completion, up to 6 months
Feasibility Criteria 2: Number of participants completing intervention protocol
10 participants completing full intervention protocol
Measured: Through to study completion, up to 6 months
Feasibility Criteria 3: Number of Valid data sets
10 complete valid data sets
Measured: Through to study completion, up to 6 months
Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
No serious adverse events
Measured: Through to study completion, up to 6 months
Secondary outcomes (7)
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.
Measured: Baseline and 2 weeks
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.
Measured: Baseline and 2 weeks
Leeds Arm Spasticity Impact Scale (LASIS)
Questionnaire assessing impact of spasticity on a person.
Measured: Baseline and 2 weeks
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.
Measured: 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)
A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.
Measured: Baseline and 2 weeks
Spinal Cord Independence Measure (SCIM) - Version 3
scale developed to address the ability of SCI patients to perform basic activities of daily living independently.
Measured: Baseline and 2 weeks
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.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ram Hariharan, MD, Study chair, Sheffield Teaching Hospitals NHS Foundation TrustAli Gharooni, Principal investigator, Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914418
- Sponsor's protocol ID
- STH18997
- Acronym
- TUSI
- Status last verified
- May 2017
- First submitted
- 23 Aug 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02914418
- Acronym / sponsor ID
- TUSI / STH18997
- Conditions
- Spinal Cord Injuries
- Keywords
- transcranial magnetic stimulation, Spinal Cord Injuries, Muscle Spasticity, Pain, Spinal Cord, Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Experimental | Device: Transcranial Magnetic Stimulation using iTBS ParadigmiTBS 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 | Sham comparator | Device: Transcranial Magnetic Stimulation using iTBS ParadigmSham 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation using iTBS ParadigmAlso: repetitive Transcranial Magnetic StimulationTMS 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. | Device | Active iTBS, Sham iTBS |
Primary outcome
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)
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
Feasibility Criteria 3: Number of Valid data sets
Time frame: Through to study completion, up to 6 months
10 complete valid data sets
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
7 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Baseline and 2 weeks
Range of Motion (RoM)
Time frame: Baseline and 2 weeks
Leeds Arm Spasticity Impact Scale (LASIS)
Time frame: Baseline and 2 weeks
Visual Analogue Scale (Spasticity) (VAS-S)
Time frame: 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
Spinal Cord Independence Measure (SCIM) - Version 3
Time frame: Baseline and 2 weeks
Visual Analogue Scale (Pain) - (VAS-P)
Time frame: Baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Hariharan, MD study chair
Sheffield Teaching Hospitals NHS Foundation Trust
Ali Gharooni principal investigator
Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation using iTBS Paradigm in people with Spinal Cord Injuries, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Criteria 1: Number of participants recruited (time frame: Through to study completion, up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.