Spinal Cord InjuriesOsStimNCT04015362
Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury
A study testing Sub-threshold intermittent pulsed magnetic stimulation in people with Spinal Cord Injuries, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Spasticity (tightening, spasming and/or contractions of muscles) is a commonly encountered consequence of injuries to the central nervous system. Spasticity has an adverse effect on quality of life and function of patients with spinal cord injuries, stroke and cerebral palsy. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Sub-threshold intermittent pulsed magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2018to 31 Oct 2022
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Aged above 18 years and below 99 years old
- Possesses mental capacity
- Established spinal cord injury Frankel grade A, B or C, at least 2 months prior to recruitment
- Involvement of the spinal cord at L1 level or above
- Admitted to the Midland Centre for Spinal Injuries (Oswestry, UK)
- Expected to remain an in-patient for the duration of the study
- Experiences spasticity affecting the lower limbs
Who cannot join
- Pregnant
- Non-MRI compatible spinal fixation in place
- Implanted Insulin pump
- Change of spasticity medication within last 2 weeks
- Planned spasticity intervention at this admission
- Epilepsy with fit within the last 12 months
Show all 22Show fewer
- Currently taking donezipil hydrochloride
- Currently taking sodium valproate
- Cardiac Pacemaker or wires
- Internal cardioverter defibrillator (ICD)
- Deep Brain Stimulator
- Tattoo on lower back
- Radioactive seeds
- Cochlear implant/ear implant
- Vagus nerve stimulator (VNS)
- Intrathecal Baclofen Pump
- presence of shrapnel, bullets, pellets, Ball bearings in the patient's body
- Wearable cardioverter defibrillator
- Surgical clips, staples or sutures
- VeriChip microtransponder
- Wearable infusion pump
- Irremovable Body piercings
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
Jayne Edwards, 01691404143, jayne.edwards5@nhs.net
Andrew Roberts
About this study
Spasticity (tightening, spasming and/or contractions of muscles) is a commonly encountered consequence of injuries to the central nervous system. Spasticity has an adverse effect on quality of life and function of patients with spinal cord injuries, stroke and cerebral palsy. Conventional management consists of medication, injections of botulinum toxin and occasionally extensive surgical interventions. Several studies have examined the use of repetitive magnetic stimulation of the brain and of peripheral nerves to produce long-term depression of spasticity. Recently, Theta burst sequence low-dose magnetic stimulation has been shown to mark unused synaptic connections for deletion. By using pulsed magnetic stimulation of the spinal cord the abnormal connections arising from injury may be identified for deletion, therefore potentially minimising the mis-firing circuits.
The investigators plan, in this pilot study, to test whether firstly the application of pulsed magnetic stimulation of the spinal cord is achievable in patients with spinal cord injury (SCI) and secondly whether it has an effect on lower limb spasticity.
Read more
These results will be used to help design a larger trial, to expand the numbers of participants and variety of pathologies treated.
Participants (in-patients at the Midland Centre for Spinal Injuries) with stable SCI will be randomised to receive either intermittent pulsed magnetic stimulation or no stimulation. Patients will be blinded as to whether they are receiving stimulation (the machine will be active up and placed in the same position for both groups, except the sham group will have the stimulation coil applied in an orientation that does not deliver the magnetic field to the spinal cord).
Read the detailed description
The investigators are trying to understand the potential for low-dose magnetic stimulation to reduce unwanted symptoms including spasticity following a spinal cord injury. After an injury to the spinal cord the nerves within the spinal cord below the level of the injury reorganise themselves. This leads to unwanted connections producing a condition known as spasticity. Spasticity is experienced by patients as unwanted muscle stiffness. In patients with some sensation this can cause pain and can often lead to problems with bones and joints and difficulties with positioning for seating and standing. Along with spasticity, altered functioning in the nerves that control blood pressure, sweating, bowel and bladder can all create difficulties for someone who has had such an injury.
It is now known that the nervous system reorganises itself on a continuous basis even after humans have finished growing. For example, it has to do this so that we can form memories and learn. This process is necessary in healthy life and is regulated by an army of cells that roam through the central nervous system including the spinal cord. These cells known as microglial cells act as gardeners, pruning connections that aren't needed and strengthening connections that are needed. From recent work in the field of biology it is now understood that a chemical called complement is used as a marker a bit like paint on a tree that is to be trimmed, to tell the microglial cells where to cut or where to strengthen. Very low level pulsed magnetic stimulation can mark connections that need to be trimmed so that the microglial cells can go about their job. The investigators want to identify whether by using a very low dose of magnetic stimulation we could reduce the abnormal connections in the spinal cord that cause spasticity. The investigators believe this is a very safe treatment because it is using magnetic stimulation on the spinal cord at a 10th of the level that is commonly used on the brain.
- Conditions
- Spinal Cord Injuries
- Being tested
- Sub-threshold intermittent pulsed magnetic stimulation, Sham
- Keywords
- Spasticity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-threshold intermittent pulsed magnetic stimulationProcedure or surgery
Application of sub-threshold intermittent pulsed magnetic stimulation to spinal cord
ShamProcedure or surgery
Application of sham magnetic stimulation to spinal cord
| Study group | Role | What they receive |
|---|---|---|
| Pulsed magnetic stimulation of the spinal cord | Experimental | Sub-threshold intermittent pulsed magnetic stimulation of spinal cord Receives: Procedure: Sub-threshold intermittent pulsed magnetic stimulation |
| Sham magnetic stimulation | Sham comparator | Sham - patient and machinery placed in same position as intervention arm but no magnetic stimulation delivered Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Penn Spasticity scale
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
Measured: Baseline (up to 24 hours before treatment)
Modified Penn Spasticity scale
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
Measured: Day 14 post start of treatment
Modified Penn Spasticity scale
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
Measured: Day 28 post start of treatment
Secondary outcomes (5)
Pain score
A patient self-reported score of pain, as published in the Spinal Cord journal 2008 (46:818-823).
Patients are initially asked whether they have had any pain in the last 7 days, including today. If no, then no further questions are asked. If yes, they are asked how many different pain problems they had (1, 2, 3, 4 or >5) and then to subsequently describe their 3 worst pain problems. Location, intensity and length of pain are then recorded. Further, questions with a scale of 0 (not at all) to 6 (extreme interference) are asked about how the patients' pain affects their daily activities, mood and sleep.
Measured: Baseline (up to 24 hours before treatment)
Pain score
A patient self-reported score of pain, as published in the Spinal Cord journal 2008 (46:818-823).
Patients are initially asked whether they have had any pain in the last 7 days, including today. If no, then no further questions are asked. If yes, they are asked how many different pain problems they had (1, 2, 3, 4 or >5) and then to subsequently describe their 3 worst pain problems. Location, intensity and length of pain are then recorded. Further, questions with a scale of 0 (not at all) to 6 (extreme interference) are asked about how the patients' pain affects their daily activities, mood and sleep.
Measured: Day 14 post start of treatment
Pain score
A patient self-reported score of pain, as published in the Spinal Cord journal 2008 (46:818-823).
Patients are initially asked whether they have had any pain in the last 7 days, including today. If no, then no further questions are asked. If yes, they are asked how many different pain problems they had (1, 2, 3, 4 or >5) and then to subsequently describe their 3 worst pain problems. Location, intensity and length of pain are then recorded. Further, questions with a scale of 0 (not at all) to 6 (extreme interference) are asked about how the patients' pain affects their daily activities, mood and sleep.
Measured: Day 28 post start of treatment
Ashworth score
A clinician assessed score of muscle tone in the hamstring, quadriceps and triceps surae. Flexion or extension of the joint is tested to score muscle tone throughout the range of motion on a scale of 0 (no increase in muscle tone) to 4 (muscle rigid). The higher the score, the more muscle spasticity is indicated.
Measured: Baseline (up to 24 hours before treatment)
Ashworth score
A clinician assessed score of muscle tone in the hamstring, quadriceps and triceps surae. Flexion or extension of the joint is tested to score muscle tone throughout the range of motion on a scale of 0 (no increase in muscle tone) to 4 (muscle rigid). The higher the score, the more muscle spasticity is indicated.
Measured: Day 14 post start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start2 Jan 2018
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Roberts, FRCS, Principal investigator, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015362
- Sponsor's protocol ID
- RL1 535
- Acronym
- OsStim
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04015362
- Acronym / sponsor ID
- OsStim / RL1 535
- Conditions
- Spinal Cord Injuries
- Keywords
- Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 11 Jul 2019 (actual)
- 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.
Spasticity (tightening, spasming and/or contractions of muscles) is a commonly encountered consequence of injuries to the central nervous system. Spasticity has an adverse effect on quality of life and function of patients with spinal cord injuries, stroke and cerebral palsy. Conventional management consists of medication, injections of botulinum toxin and occasionally extensive surgical interventions. Several studies have examined the use of repetitive magnetic stimulation of the brain and of peripheral nerves to produce long-term depression of spasticity. Recently, Theta burst sequence low-dose magnetic stimulation has been shown to mark unused synaptic connections for deletion. By using pulsed magnetic stimulation of the spinal cord the abnormal connections arising from injury may be identified for deletion, therefore potentially minimising the mis-firing circuits.
The investigators plan, in this pilot study, to test whether firstly the application of pulsed magnetic stimulation of the spinal cord is achievable in patients with spinal cord injury (SCI) and secondly whether it has an effect on lower limb spasticity.
These results will be used to help design a larger trial, to expand the numbers of participants and variety of pathologies treated.
Participants (in-patients at the Midland Centre for Spinal Injuries) with stable SCI will be randomised to receive either intermittent pulsed magnetic stimulation or no stimulation. Patients will be blinded as to whether they are receiving stimulation (the machine will be active up and placed in the same position for both groups, except the sham group will have the stimulation coil applied in an orientation that does not deliver the magnetic field to the spinal cord).
Detailed description
The investigators are trying to understand the potential for low-dose magnetic stimulation to reduce unwanted symptoms including spasticity following a spinal cord injury. After an injury to the spinal cord the nerves within the spinal cord below the level of the injury reorganise themselves. This leads to unwanted connections producing a condition known as spasticity. Spasticity is experienced by patients as unwanted muscle stiffness. In patients with some sensation this can cause pain and can often lead to problems with bones and joints and difficulties with positioning for seating and standing. Along with spasticity, altered functioning in the nerves that control blood pressure, sweating, bowel and bladder can all create difficulties for someone who has had such an injury.
It is now known that the nervous system reorganises itself on a continuous basis even after humans have finished growing. For example, it has to do this so that we can form memories and learn. This process is necessary in healthy life and is regulated by an army of cells that roam through the central nervous system including the spinal cord. These cells known as microglial cells act as gardeners, pruning connections that aren't needed and strengthening connections that are needed. From recent work in the field of biology it is now understood that a chemical called complement is used as a marker a bit like paint on a tree that is to be trimmed, to tell the microglial cells where to cut or where to strengthen. Very low level pulsed magnetic stimulation can mark connections that need to be trimmed so that the microglial cells can go about their job. The investigators want to identify whether by using a very low dose of magnetic stimulation we could reduce the abnormal connections in the spinal cord that cause spasticity. The investigators believe this is a very safe treatment because it is using magnetic stimulation on the spinal cord at a 10th of the level that is commonly used on the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed magnetic stimulation of the spinal cord | Experimental | Procedure: Sub-threshold intermittent pulsed magnetic stimulationSub-threshold intermittent pulsed magnetic stimulation of spinal cord |
| Sham magnetic stimulation | Sham comparator | Procedure: ShamSham - patient and machinery placed in same position as intervention arm but no magnetic stimulation delivered |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide informed consent
- Aged above 18 years and below 99 years old
- Possesses mental capacity
- Established spinal cord injury Frankel grade A, B or C, at least 2 months prior to recruitment
- Involvement of the spinal cord at L1 level or above
Key exclusion criteria (22 listed)
- Pregnant
- Non-MRI compatible spinal fixation in place
- Implanted Insulin pump
- Change of spasticity medication within last 2 weeks
- Planned spasticity intervention at this admission
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 |
|---|---|---|
| Sub-threshold intermittent pulsed magnetic stimulationApplication of sub-threshold intermittent pulsed magnetic stimulation to spinal cord | Procedure or surgery | Pulsed magnetic stimulation of the spinal cord |
| ShamApplication of sham magnetic stimulation to spinal cord | Procedure or surgery | Sham magnetic stimulation |
Primary outcome
Modified Penn Spasticity scale
Time frame: Baseline (up to 24 hours before treatment)
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
Modified Penn Spasticity scale
Time frame: Day 14 post start of treatment
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
Modified Penn Spasticity scale
Time frame: Day 28 post start of treatment
A two-part patient self-reported measure assessing frequency and severity of muscle spasms. Part one asks the patient to describe the intensity and frequency of muscle spasms in the previous 24 hours and part two asks the patient to describe the intensity and frequency of muscle spasms in the previous 1 hour. Frequency is assessed on a 5 point scale ranging from no spasms (0) to spontaneous spasms occurring more than 10 times in the hour (5). Intensity it marked on a 3 point scale of mild, moderate and severe. The higher the scores, the more frequent and the more severe the spasms.
5 secondary outcomes
Pain score
Time frame: Baseline (up to 24 hours before treatment)
Pain score
Time frame: Day 14 post start of treatment
Pain score
Time frame: Day 28 post start of treatment
Ashworth score
Time frame: Baseline (up to 24 hours before treatment)
Ashworth score
Time frame: Day 14 post start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
Andrew Roberts, FRCS principal investigator
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-threshold intermittent pulsed magnetic stimulation in people with Spinal Cord Injuries, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS 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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayne Edwards (01691404143, jayne.edwards5@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Penn Spasticity scale (time frame: Baseline (up to 24 hours before treatment)). The study lists 3 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 1 Feb 2022.