UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005279 |
|---|---|
| Receipt number | R000006276 |
| Scientific Title | Transcranial magnetic stimulation (TMS) in the treatment of nicotine dependence: A single-blind, randomized, sham-controlled crossover trial |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2014/03/27 17:27:27 |
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Basic information
Public title
Transcranial magnetic stimulation (TMS) in the treatment of nicotine dependence: A single-blind, randomized, sham-controlled crossover trial
Acronym
Transcranial magnetic stimulation (TMS) in the treatment of nicotine dependence
Scientific Title
Transcranial magnetic stimulation (TMS) in the treatment of nicotine dependence: A single-blind, randomized, sham-controlled crossover trial
Scientific Title:Acronym
Transcranial magnetic stimulation (TMS) in the treatment of nicotine dependence
Region
| Japan |
Condition
Condition
Nicotine dependence
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are 1) to investigate the efficacy of transcranial magnetic stimulation (TMS) over the prefrontal cortex in patients with nicotine dependence and 2) to clarify the neurophysiological mechanism of nicotine dependence using high-resolution electroencephalography (EEG).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fagerstrome Test for Nicotine Dependence (FTND); Tobacco Dependence Screener (TDS); Visual analogue scale for nicotine craving (VAS); Visual analogue scale for mood (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
TMS will be applied in the left and right prefrontal cortex.
Left Sham, Washout (over 2 days), Left TMS
Left TMS, Washout (over 2 days), Left Sham
Interventions/Control_2
Right Sham, Washout (over 2 days), Right TMS
Right TMS, Washout (over 2 days), Right Sham
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with DSM-IV-TR of nicotine dependence
2) Age of patients between 20-65 years
3) Smoking at least 20 cigarettes per day
Key exclusion criteria
1) Taking psychiatric medications
2) Schizophrenia, personality disorders, history of neurological disorders or organic brain disorders
3) History of convulsive disorders
4) Drug or alcohol abuse/dependence
5) Implanted electronic devices/magnetic material
6) Severe physical diseases, endocrine diseases
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 19 | Day |
Last modified on
| 2014 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006276
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
