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

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

30

Neuropathic pain at upper extremity n=30 Age Mean (SD) 67.0 (9.7) Sex (male) 19 (63%) Pain duration (month) median (interquartile range) 68 (36-126) Cause of pain: Central neuropathic pain: 25 (83%), Peripheral neuropathic pain: 5 (17%) Pain side: bilateral 12, left side 8, right side 10 Treated painful region: right upper limb 15, left upper limb 15

The jRCT initial publication was made on February 20, 2020, and enrollment began on March 2, 2020. Thirty-two study subjects were enrolled in first registration after written consent to participate in this clinical study was obtained, and two cases were not enrolled in secondary registration (ineligible cases). There were 30 cases in the safety analysis set and the full analysis set. There were 2 cases of discontinuation due to subject-related factors (dropout cases) and 28 cases in the per protocol set. Both dropout cases were determined not to be causally related to the intervention.

Four adverse events occurred. Three of them had no direct causal association with the study and were all non-serious, and one was transient, minor and non-serious, although a causal association with the intervention could not be ruled out. Based on the above, we consider that none of the adverse events that occurred in this study was a serious disease or other minor event, and therefore, there are no safety issues in this clinical study.

The intervention was performed with 14 patients assigned to the active stimulation group and 16 to the sham stimulation group. After the last intervention, the reduction on the pain scale was 0.84 (95CI: 0.21-1.47) for the active stimulation group and 0.58 (-0.01-1.17) for the sham stimulation group, but there was no interaction between treatment group and time point on the primary outcome. Similar to the results of the primary outcome, the secondary outcomes were not statistically effective in the interaction between treatment group and time point. At week 9, 5 cases (36%) for active stimulation responded "minimally improved" or more on PGIC and 3 cases (19%) for sham stimulation.

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.

Oct. 01, 2022

No

None

https://jrct.niph.go.jp/latest-detail/jRCTs052190110

Hosomi Koichi

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

k-hosomi@nsurg.med.osaka-u.ac.jp

Hosomi Koichi

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

+81-6-6879-3652

k-hosomi@nsurg.med.osaka-u.ac.jp

Complete

Feb. 20, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

<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

<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

Both

neuropathic pain

repetitive transcranial magnetic stimulation

chronic pain, intractable pain

noninvasive brain stimulation

D050781

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

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

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