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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000025975 |
Receipt No. | R000028176 |
Scientific Title | Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain |
Date of disclosure of the study information | 2017/03/01 |
Last modified on | 2019/07/31 |
Basic information | ||
Public title | Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain | |
Acronym | Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain | |
Scientific Title | Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain | |
Scientific Title:Acronym | Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain | |
Region |
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Condition | ||||
Condition | intractable pain | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To explore optimal conditions of non-invasive brain stimualtion for treating intractable pain, and to investigate safety and feasibility of the long-term application |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Pain reduction in VAS
Pain reduction in NRS |
Key secondary outcomes | Frequency and duration of shooting pain, if a subject has a shooting pain
Pain reduction in SF-MPQ 2 (Short form of McGill pain questionnaire 2) PGIC (Patient global impression of change) Improvement in PDAS (Pain Disability Assessment Scale) Improvement in EQ-5D Improvement in PCS (Pain Catastrophizing Scale) Improvement in HADS (Hospital Anxiety and Depression Scale) Change in BDI-II |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 6 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Active rTMS, condition 1
single session |
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Interventions/Control_2 | Active rTMS, condition 2
single session |
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Interventions/Control_3 | Active rTMS, condition 3
single session |
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Interventions/Control_4 | Sham rTMS
single session |
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Interventions/Control_5 | Active tDCS
single session |
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Interventions/Control_6 | Sham tDCS
single session |
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with intractable pain for 6 months or longer
2)Patients with 30mm or more in VAS at baseline 3)Patients with insufficient pain relief, despite receiving drugs for pain, or a history of using drugs for pain 4)Patients with an informed consent given |
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Key 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 cardiac stimulator 7)Patients with an implantable deep brain stimulation devices 8)Patients with an implanted metal in their heads, except for titanium products 9)Pregnant patients 10)Patients who cannot write questionaires 11)Patients without ability of agreements 12)Patients receiving other clinical trials or studies within 6 months before agreements 13)Patients who are considered unsuitable for this clinical trial by a principal or sub investigator 14)Patients with a scalp lesion on the stimulation site (tDCS) |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka University | ||||||
Division name | Department of Neuromodulation and Neurosurgery | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan | ||||||
TEL | +81-6-6210-8435 | ||||||
saitoh@nsurg.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka University | ||||||
Division name | Department of Neuromodulation and Neurosurgery | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan | ||||||
TEL | +81-6-6210-8435 | ||||||
Homepage URL | |||||||
k-hosomi@nsurg.med.osaka-u.ac.jp |
Sponsor | |
Institute | Osaka University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Osaka University, Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 大阪大学医学部附属病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028176 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |