Efficacy of deep rTMS for neuropathic pain in the lower limb: a randomized, double-blind crossover trial of an H-coil and figure-8 coil.
OBJECTIVE Electrical motor cortex stimulation can relieve neuropathic pain (NP), but its use requires patients to undergo an invasive procedure. Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) using a figure-8 coil can relieve NP noninvasively, but its ability to relieve lower limb pain is still limited. Deep rTMS using an H-coil can effectively stimulate deep brain regions and has been widely used for the treatment of various neurological diseases; however, there have been no clinical studies comparing the effectiveness of figure-8 coils and H-coils. This study assessed the clinical effectiveness of 5 once-daily stimulations with H-coils and figure-8 coils in patients with NP. METHODS This randomized, double-blind, 3-way crossover trial examined 18 patients with NP who sequentially received 3 types of stimulations in the M1 for 5 consecutive days; each 5-day stimulation period was followed by a 17-day follow-up period before crossing over to the next type of stimulation. During each rTMS session, patients received a 5-Hz rTMS to the M1 region corresponding to the painful lower limb. The visual analog scale (VAS) and the Japanese version of the short-form McGill Pain Questionnaire 2 (SF-MPQ2-J) were used to measure pain intensity. The primary outcome was VAS score reduction immediately after and 1 hour after intervention. RESULTS Both the VAS and SF-MPQ2-J showed significant pain improvement immediately after deep rTMS with an H-coil as compared with the sham group (p < 0.001 and p = 0.049, respectively). However, neither outcome measure showed significant pain improvement when using a figure-8 coil. The VAS also showed significant pain improvement 1 hour after deep rTMS with an H-coil (p = 0.004) but not 1 hour after rTMS using a figure-8 coil. None of the patients exhibited any serious adverse events. CONCLUSIONS The current findings suggest that the use of deep rTMS with an H-coil in the lower limb region of the M1 in patients with NP was tolerable and could provide significant short-term pain relief. Clinical trial registration no.: UMIN000010536 ( http://www.umin.ac.jp/ctr/ ).
Departments of 1 Neuromodulation and Neurosurgery.|Neurosurgery, and.|Center for Pain Management, Osaka University Hospital, Suita.
Takeshi
T
Shimizu
Departments of 1 Neuromodulation and Neurosurgery.|Neurosurgery, and.|Center for Pain Management, Osaka University Hospital, Suita.
Koichi
K
Hosomi
Departments of 1 Neuromodulation and Neurosurgery.|Neurosurgery, and.|Department of Neurosurgery, Otemae Hospital, Osaka.
Tomoyuki
T
Maruo
Departments of 1 Neuromodulation and Neurosurgery.|Neurosurgery, and.
Yuko
Y
Goto
Departments of 1 Neuromodulation and Neurosurgery.|Neurology, Osaka University Graduate School of Medicine.
Masaru
M
Yokoe
Neurosurgery, and.|Department of Neurosurgery, Saitama Children's Medical Center, Saitama; and.
Yu
Y
Kageyama
Clinical Research Center, Wakayama Medical University, Wakayama, Japan.
Toshio
T
Shimokawa
Neurosurgery, and.|Center for Pain Management, Osaka University Hospital, Suita.
Toshiki
T
Yoshimine
Departments of 1 Neuromodulation and Neurosurgery.|Neurosurgery, and.|Center for Pain Management, Osaka University Hospital, Suita.
Youichi
Y
Saitoh
D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D009044:Motor Cortex / Q000503:physiopathology*; D009437:Neuralgia / Q000503:physiopathology / Q000628:therapy*; D059408:Pain Management; D010147:Pain Measurement; D050781:Transcranial Magnetic Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
ANOVA = analysis of variance; BDI = Beck Depression Inventory; CPSP = central poststroke pain; EMCS = electrical motor cortex stimulation; FBSS = failed–back surgery syndrome; H-coil; H-coil = Hesed coil; M1 = primary motor cortex; NP = neuropathic pain; PGIC = patient global impression of change; RMT = resting motor threshold; SCD = subacute combined degeneration; SCI = spinal cord injury; SF-MPQ2-J = short-form McGill Pain Questionnaire 2, Japanese version; TCS = tethered spinal cord syndrome; TMS = transcranial magnetic stimulation; VAS = visual analog scale; deep rTMS; figure-8 coil; lower limb pain; neuropathic pain; rTMS = repetitive transcranial magnetic stimulation; repetitive transcranial magnetic stimulation