Trial of long-term rTMS therapy for intractable neuropathic pain - TMS-P-07

Hosomi Koichi0 sites30 target enrollmentFebruary 20, 2020

Conditionsneuropathic pain chronic pain, intractable pain

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: neuropathic pain
Sponsor: Hosomi Koichi
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study was an exploratory, randomized, placebo-controlled trial to evaluate the efficacy and safety of 10-Hz repetitive transcranial magnetic stimulation over the primary motor cortex of hand area in 30 patients with neuropathic pain in the upper extremity. The primary outcome didn't show that the active stimulation group wasn't more effective than the sham. No serious adverse eventswere observed.

Registry

who.int

Start Date

February 20, 2020

End Date

December 9, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hosomi Koichi

Eligibility Criteria

Inclusion Criteria

•1\) Patients with neuropathic pain longer than 6 months after onset.
•2\) Baseline VAS of pain intensity: 40 to 95/100 mm
•3\) Patients with currently prescribed medication for NP or a history of being prescribed multiple medications for NP without achieving pain control
•4\) Patients with continuous pain at upper extremity
•5\) Age \>\= 20 years
•6\) Patients with written consent for participation in this study
•1\) Average of pain diary (NRS) 1 week before intervention: \>\= 4
•2\) Average of VAS 1 week before intervention: \>\= 40 mm

Exclusion Criteria

•1\) Patients with dementia (MMSE \=\< 23\)
•2\) Patients with severe aphasia and cognitive dysfunction
•Patients with severe mental illness
•Patients with a history of drug abuse or addiction (including alcoholism) within the last one yea
•3\) Patients with suicidal thoughts
•4\) Patients with a history of seizures
•5\) Patients with cardiac pacemakers or other types of implantable stimulator (except implantable spinal cord stimulator)
•6\) Patients with metal object (excluding Titanium products) embedded in the head
•7\) Patients with implantable pump or implantable ventricular assist devices
•8\) Pregnant patients