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Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury

NCT04015362 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-01

No results posted yet for this study

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).

Conditions

  • Spinal Cord Injuries

Interventions

PROCEDURE

Sub-threshold intermittent pulsed magnetic stimulation

Application of sub-threshold intermittent pulsed magnetic stimulation to spinal cord

PROCEDURE

Sham

Application of sham magnetic stimulation to spinal cord

Sponsors & Collaborators

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Andrew Roberts, FRCS · The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015362 on ClinicalTrials.gov