Trial of long-term rTMS therapy for intractable neuropathic pai

Phase 2

• Conditions: neuropathic pain; chronic pain, intractable pain

• Registration Number: JPRN-jRCTs052190110
• Lead Sponsor: Hosomi Koichi

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Study Completion: 2021-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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
9) Patients unable to answer the questionnaires
10) Patients whose stimulus target upper extremities are in complete paralysis condition
11) Patients who received rTMS within the last six months before obtaining consent
12) Patients who enrolled in any other clinical trials or clinical studies within the last three months before obtaining consent
13) Others not applicable person determined by the investigators

1) Patients who are unable to comply combination prohibited or combination restricted therapies during the observation period
2) Patients who are able to fill in the evaluation forms for less than five days during the observation period
3) Others not applicable person determined by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in the weekly average of pain diary (NRS) at each week (week 1 to 8) compared with baseline