Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury
OsStim
1 other identifier
interventional
30
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2018
CompletedFirst Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedFebruary 1, 2022
January 1, 2022
4.8 years
April 26, 2019
January 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Day 28 post start of treatment
Secondary Outcomes (5)
Pain score
Baseline (up to 24 hours before treatment)
Pain score
Day 14 post start of treatment
Pain score
Day 28 post start of treatment
Ashworth score
Baseline (up to 24 hours before treatment)
Ashworth score
Day 14 post start of treatment
Study Arms (2)
Pulsed magnetic stimulation of the spinal cord
EXPERIMENTALSub-threshold intermittent pulsed magnetic stimulation of spinal cord
Sham magnetic stimulation
SHAM COMPARATORSham - patient and machinery placed in same position as intervention arm but no magnetic stimulation delivered
Interventions
Application of sub-threshold intermittent pulsed magnetic stimulation to spinal cord
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Roberts, FRCS
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
July 11, 2019
Study Start
January 2, 2018
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
February 1, 2022
Record last verified: 2022-01