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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016163
Receipt No. R000018760
Scientific Title Neural mechanism of impulse control on addiction by tDCS and a cognitive neuroscience approach
Date of disclosure of the study information 2015/01/08
Last modified on 2015/01/08

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Basic information
Public title Neural mechanism of impulse control on addiction by tDCS and a cognitive neuroscience approach
Acronym A treatment option to zolpidem and nicotine dependence by tDCS
Scientific Title Neural mechanism of impulse control on addiction by tDCS and a cognitive neuroscience approach
Scientific Title:Acronym A treatment option to zolpidem and nicotine dependence by tDCS
Region
Asia(except Japan)

Condition
Condition A treatment option for substance dependence
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 study aimed to evaluate potential therapeutic effects of prefrontal tDCS for the treatment of substance dependence. tDCS is a safe, powerful and non-invasive way to modulate brain activity as mentioned previously. tDCS would be applied for 10 sessions (1 session/day, 5 consecutive days/ week x 2 weeks). The study is scheduled for two years: first year would be focusing on zolpidem dependence and second year on nicotine dependece.
Basic objectives2 Others
Basic objectives -Others It is still not clear that neural mechanism of impulse control on addiction by tDCS and neurocognitive effect by tDCS.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes BZD dependence self report questionnaire for craving of Zolpidem; Fagerstrom Test for Nicotine Dependence (FTND) for Nicotine dependence; Visual analogue scale (VAS);Depression and somatic symptoms scale (DSSS);
Key secondary outcomes Nerocognitive testings will be also performed three times, baseline, Day 5 and 2 weeks post-treatment Go/no-go back; CANTAB

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Anodal stimulation of the left DLPFC:
The anode place at the left DLPFC and cathode placed at the right DLPFC, stimulated by tDCS. A constant current of 2mA intensity, provided by battery, was applied for 20 minutes. Stimulation with 2 mA for a single session per day. Total 10 sessions for 10 days.
Interventions/Control_2 Anodal stimulation of the right DLPFC:
The anode place at the right DLPFC and cathode placed at the left DLPFC, stimulated by tDCS. A constant current of 2mA intensity, provided by battery, was applied for 20 minutes. Stimulation with 2 mA for a single session per day. Total 10 sessions for 10 days.
Interventions/Control_3 Sham stimulation of DLPFC: electrodes placed at the bilateral DLPFC as active groups, which anode at right DLPFC in half of participants and anode at left DLPFC in another half of participants but turned off after 30 seconds of stimulation. A constant current of 2mA intensity, provided by battery, but turned off after 30 seconds of stimulation.Total 10 sessions for 10 days
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
21 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria (1) Meet the Structured Clinical Interview for DSM-IV(SCID)criteria for Zolpidem/Nicotine dependence, and the duration over one year
(2) Evaluate the comorbidity by MINI interview
Key exclusion criteria the ones who suffer from the severe medical (i.e.: arrhythmia) or brain-injury disease (i.e.: histories ofneurostimulator implantation stroke, epilepsy, brain tumor, brain infection, brain hemorrhage, brain pressure elevation); pregnant woman; neuro-device implantation; Pacemaker; Surgical intervention of brain.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +81-188628757027
Email on5083@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +81-188628757027
Homepage URL
Email on5083@msn.com

Sponsor
Institute Taipei Veterans General Hospital, Taiwan
Institute
Department

Funding Source
Organization Taipei Veterans General Hospital, Taiwan
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Taiwan, ROC

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
2015 Year 01 Month 08 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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 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
2015 Year 01 Month 08 Day
Last modified on
2015 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018760

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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