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NCT04015362: OsStim
Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury
NA trial testing Sub-threshold intermittent pulsed magnetic stimulation in Spinal Cord Injuries in 30 participants. Status unknown.
31 October 2022
Quick facts
| Lead sponsor | Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 2 January 2018 |
| Primary completion | 31 October 2022 |
| Estimated completion | 31 October 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Sub-threshold intermittent pulsed magnetic stimulation
- Sham
Conditions studied
- Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust — full company profile →
Who can join
Adults 18 to 99, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04015362
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Spinal Cord Injuries
Currently open trials in the same condition.
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- NCT07210411 — Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury · NA · recruiting
- NCT07488793 — Remote Ischemic Conditioning for PwSCI · NA · recruiting
- NCT07536386 — Self-balancing Personal Exoskeleton for SCI (WIP) · NA · recruiting
Other Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust trials
Trials by the same sponsor.
- NCT07102563 — Biological Link Between Anxiety and Outcomes Post Knee Arthroplasty · not yet recruiting
- NCT06895239 — Elbow Arthroplasty and Patient Reported Post-operative Activities · not yet recruiting
- NCT07060469 — Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty. · not yet recruiting
- NCT07014306 — The Oswestry Metabolic BONE Cohort · not yet recruiting
- NCT06782269 — Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04015362 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Last refreshed: 1 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04015362.
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