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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005279
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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