Trial of long-term rTMS therapy for intractable neuropathic pain

JRCT ID: jRCTs052190110

Registered date:20/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: neuropathic pain
• Date of first enrollment: 02/03/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): repetitive transcranial magnetic stimulation

Outcome(s)

• Primary Outcome: Decrease in the weekly average of pain diary (NRS) at each week (week 1 to 8) compared with baseline

Secondary Outcome

1) Pain diary
Decrease rate of the weekly average of pain diary (NRS) at each time point compared with baseline
Ratio of patients that showed >= 2 decrease in the weekly average of pain diary (NRS) at week 8
Ratio of patients that showed >= 4 decrease in the weekly average of pain diary (NRS) at week 8
Ratio of patients that showed >= 30% decrease in the weekly average of pain diary (NRS) at week 8
Ratio of patients that showed >= 50% decrease in the weekly average of pain diary (NRS) at week 8
2) VAS
Decrease and decrease rate of VAS at each time point compared with baseline
Ratio of patients that showed >= 20 mm decrease in VAS at week 9
Ratio of patients that showed >= 40 mm decrease in VAS at week 9
Ratio of patients that showed >= 30% decrease in VAS at week 9
Ratio of patients that showed >= 50% decrease in VAS at week 9
3) SF-MPQ2
Decrease and decrease rate of SF-MPQ2 total score at each time point compared with baseline
Ratio of patients that showed >= 30% decrease in SF-MPQ2 total score at week 9
Ratio of patients that showed >= 50% decrease in SF-MPQ2 total score at week 9
Decrease and decrease rate of SF-MPQ2 each subscale score (continuous pain, intermittent pain, neuropathic pain, affective descriptors) at each time point compared with baseline
Ratio of patients that showed >= 30% decrease in SF-MPQ2 each subscale score at week 9
Ratio of patients that showed >= 50% decrease in SF-MPQ2 each subscale score at week 9
Decrease and decrease rate of SF-MPQ2 each item at each time point compared with baseline
Ratio of patients that showed >= 30% decrease in SF-MPQ2 each item at week 9
Ratio of patients that showed >= 50% decrease in SF-MPQ2 each item at week 9
4) VAS immediately after intervention
Decrease and decrease rate of VAS immediately after each intervention compared with baseline
Decrease and decrease rate of VAS immediately after intervention during induction period (day 1 to 5) compared with baseline
Ratio of patients that showed >= 10 mm decrease in VAS immediately after intervention during induction period (day 1 to 5)
Ratio of patients that showed >= 20 mm decrease in VAS immediately after intervention during induction period (day 1 to 5)
Ratio of patients that showed >= 10% decrease in VAS immediately after intervention during induction period (day 1 to 5)
Ratio of patients that showed >= 15% decrease in VAS immediately after intervention during induction period (day 1 to 5)
Ratio of patients that showed >= 30% decrease in VAS immediately after intervention during induction period (day 1 to 5)
5) PGIC
PGIC at each time point
Ratio of patients that showed >= "minimally improved" in PGIC at each time point
Ratio of patients that showed >= "much improved" in PGIC at each time point
6) PCS
Decrease in PCS at week 9 compared with baseline
Decrease in PCS each subscale score (rumination, helplessness, magnification) at week 9 compared with baseline
7) PDAS
Decrease in PDAS at week 9 compared with baseline
8) EQ-5D-5L
Increase in the QOL value of EQ-5D-5L at week 9 compared with baseline
9) BDI-II
Decrease in BDI-II at week 9 compared with baseline
Ratio of patients that showed >= 5 decrease in BDI-II at week 9
10) MMSE
Increase in MMSE at week 9 compared with baseline
11) Safety
Adverse event
12) Blinding assessment
Ratio of patient's guess of assigned intervention at week 9

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

<First registration>
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
<Second registration>
1) Average of pain diary (NRS) 1 week before intervention: >= 4
2) Average of VAS 1 week before intervention: >= 40 mm

Exclude criteria

<First registration>
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
<Second registration>
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

Related Information

• Primary Sponsor: Hosomi Koichi