UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016163 |
|---|---|
| Receipt number | 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 17:43:53 |
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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
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
on5083@msn.com
Sponsor or person
Institute
Taipei Veterans General Hospital, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018760
