A study to investigate the mechanism of repetitive peripheral magnetic stimulation in the treatment of spasticity1

Phase 1

Recruiting

• Conditions: central motor palsy

• Registration Number: JPRN-UMIN000051286
• Lead Sponsor: Keio University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-08
• Last Update Posted: 17 October 2023
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1) Those who have a cardiac pacemaker or artificial heart valve 2) Patients with an indwelling catheter in the heart 3) Patients with severe cardiac disease 4) Patients with obvious intracranial hypertension 5) Patients using a medical pump 6) Dependent on intra- or extracorporeal life support devices 7) Who have surgical clips or ferromagnetic materials in their body to stop bleeding 8) Who have a cochlear implant 9) Who may have metal fragments in their body 10) Persons with a history of convulsions or syncope 11) Persons with a history or family history of epilepsy 12) Persons with a history of suspected epilepsy or a family history of epilepsy 13) Persons with recent burns or skin lesions on the affected area 14) Patients with serious orthopedic complications that interfere with movement 15) Patients with a history of neuromuscular disease 16) Persons with other recent acute systemic illnesses or unstable general condition 17) Persons with severe dementia or complications of severe mental illness 18) Persons who may be pregnant 19) Other persons deemed inappropriate by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate repressive inhibition before, immediately after, 15 minutes after, and 30 minutes after stimulation with rPMS or NMES.

Secondary Outcome Measures

Name	Time	Method
- Spasticity (modified Ashworth scale, modified Tardieu scale, foot clonus) (pre-stimulation, 30 minutes after stimulation) - Physiological assessment (surface electromyography, motor evoked potentials) (pre-stimulation, immediately after stimulation, 15 minutes, 30 minutes after stimulation) - Joint range of motion (pre-stimulation, 30 minutes after stimulation)