Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence
Comparison of Anti-craving Efficacy of Right and Left Prefrontal High Frequency rTMS in Alcohol Dependence: a Randomized Double-blind Study
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
Null hypothesis: There will be no significant difference in the change in craving parameters between right and left prefrontal high frequency rTMS in patients with alcohol dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 22, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedMarch 26, 2010
March 1, 2010
6 months
March 22, 2010
March 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Craving
Alcohol Craving Questionnaire (ACQ-NOW) total score
2 weeks
Secondary Outcomes (1)
Craving
2 weeks
Study Arms (1)
rTMS
EXPERIMENTALCompare the change in craving parameters following high frequency rTMS stimulation of right and left DLPFC in patients with alcohol dependence
Interventions
Ten daily sessions of rTMS treatments using Magstim Rapid® device (10 Hz, 110% of the MT, 4.9 seconds per train, inter-train interval of 30 seconds, and 20 trains per session) with an air cooled figure-of-eight coil over either right or left DLPFC
Eligibility Criteria
You may qualify if:
- Diagnosis of Alcohol dependence syndrome according to ICD-10 DCR,
- Male patients aged between 18-60 years,
- Patients with CIWA-Ar scores ≤10,
- Right handed, normotensive patients,
- Patients giving written informed consent.
You may not qualify if:
- Comorbid psychiatric, major medical or neurological disorders,
- History of withdrawal seizures, delirium tremens or significant head injury,
- Subjects with pacemaker or metal in any part of the body excluding the mouth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Mishra BR, Praharaj SK, Katshu MZ, Sarkar S, Nizamie SH. Comparison of anticraving efficacy of right and left repetitive transcranial magnetic stimulation in alcohol dependence: a randomized double-blind study. J Neuropsychiatry Clin Neurosci. 2015 Winter;27(1):e54-9. doi: 10.1176/appi.neuropsych.13010013.
PMID: 25255169DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
S Haque Nizamie
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 22, 2010
First Posted
March 26, 2010
Study Start
August 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 26, 2010
Record last verified: 2010-03