Intractable neuropathic pain
Conditions
Interventions
Active stimulation (primary motor cortex) for 5 days The patients who fulfil the required conditions receive active stimualtions in the extension period (once a week or more)
Sham stimulation for 5 d
Sponsors
Osaka University Medical Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with intractable neuropathic pain for 6 months or longer 2)Patients with 30-94 mm in VAS at baseline 3)Patients with insufficient pain relief, despite receiving drugs for neuropathic pain, or a history of using more than a drug for neuropathic pain 4)Patients with continuous pain in extremities or face 5)Patients with an informed consent given
Exclusion criteria
Exclusion criteria: 1)Patients with dementia (MMSE=<24) 2)Patients with severe aphasia or higher brain dysfunction 3)Patients with a major psychiatric disease 4)Patients with a desire for suicide 5)Patients with a history of epileptic attacks 6)Patients with an implantable stimulator including a cardiac pacemaker, except an impantable spinal cord stimulator 7)Patients with an implanted metal, except for titanium products, in their heads 8)Patients with an implanted pump or mechanical heart 8)Patients who cannot write questionaires 9)Patients showing complete paralysis in painful evaluation area 10)Patients without ability of agreements 11)Patients receiving rTMS within a year before agreements 12)Patients receiving other clinical trials or studies within 6 months before agreements 13)Compliance of patients for prohibited drugs and treatments is under 80% 14)Patients who are considered unsuitable for this clinical trial by a principal or sub investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS reduction from baseline (i.e. before the intervention on the first day) just after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain reduction rate in VAS Pain reduction and pain reduction rate of VAS in short term Pain reduction and pain reduction rate of VAS just before intervention Reduction and reduction rate of SF-MPQ2 Reduction and reduction rate of SF-MPQ2 in short term Reduction and reduction rate of SF-MPQ2 just before intervention Amount and rate of change in the QOL score of EQ-5D-5L Amount and rate of change in the visual analogue scale of EQ-5D-5L Rate of subjects with 10mm VAS reduction or more Rate of subjects with 20mm VAS reduction or more Rate of subjects with 15% VAS reduction rate or more Rate of subjects with 30% VAS reduction rate or more Rate of subjects showing "minimally improved" or more in PGIC Rate of subjects showing "much improved" or more in PGIC Rate of subjects showing 5 points or more improvement in BDI-II | — |
Countries
Japan
Contacts
Public ContactKoichi Hosomi
Osaka University Department of Neuromodulation and Neurosurgery
Outcome results
None listed