Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magstim Rapid® (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Craving, rTMS, Dorsolateral prefrontal cortex
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rTMS
Arm Description
Compare the change in craving parameters following high frequency rTMS stimulation of right and left DLPFC in patients with alcohol dependence
Outcomes
Primary Outcome Measures
Craving
Alcohol Craving Questionnaire (ACQ-NOW) total score
Secondary Outcome Measures
Craving
Alcohol Craving Questionnaire (ACQ-NOW) factor scores
Full Information
NCT ID
NCT01093716
First Posted
March 22, 2010
Last Updated
March 25, 2010
Sponsor
Central Institute of Psychiatry, Ranchi, India
1. Study Identification
Unique Protocol Identification Number
NCT01093716
Brief Title
Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence
Official Title
Comparison of Anti-craving Efficacy of Right and Left Prefrontal High Frequency rTMS in Alcohol Dependence: a Randomized Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Institute of Psychiatry, Ranchi, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The patients clinically diagnosed as Alcohol dependence syndrome (F 10.24) according to ICD-10 DCR, fulfilling the inclusion and exclusion criteria will be taken up for the study. A detailed physical examination will be done to rule out any major medical or neurological disease. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. To ensure that the patients selected are right handed, Handedness Preference Schedule will be applied. Socio-demographic data will be collected. Baseline SADQ-C and CIWA-Ar will be administered to determine the severity of alcohol dependence and the intensity of withdrawal symptoms respectively. When the CIWA-Ar score becomes ≤ 10, then they will be taken up for rTMS application. For these patients baseline ACQ-NOW will be administered to measure the baseline craving. Patients will be randomly allocated into two groups using randomization table. The first group will receive active rTMS of the right pre-frontal cortex; the second group will be administered active rTMS of the left pre-frontal cortex. Each patient will receive rTMS sessions 5 days a week for 2 weeks. ACQ-NOW score will again be documented in both the groups after the last rTMS session to observe the changes in craving parameters. The rating will be done by one of the authors who will be blind to the nature of rTMS stimulation being administered to the patients.
The motor threshold (MT) for the left abductor pollicis brevis will be determined by a figure of 8 shaped coil, using the Rossini-Rothwell method. MT will be defined as the lowest intensity, which produces 5 motor evoked potential (MEP) responses of at least 50 µV in 10 trials. The prefrontal cortex rTMS stimulation site will be determined by measuring 5 cm anterior and in a parasagittal line from the point of maximum stimulation of left abductor pollicis muscle. Ten active rTMS treatments will be administered at 10 Hz frequency, over right or left prefrontal cortex at 110% of MT for duration of 5 seconds and 20 trains per session, with the coil-angled tangentially to the head.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Craving, rTMS, Dorsolateral prefrontal cortex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Experimental
Arm Description
Compare the change in craving parameters following high frequency rTMS stimulation of right and left DLPFC in patients with alcohol dependence
Intervention Type
Device
Intervention Name(s)
Magstim Rapid® (rTMS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Craving
Description
Alcohol Craving Questionnaire (ACQ-NOW) total score
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Craving
Description
Alcohol Craving Questionnaire (ACQ-NOW) factor scores
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Haque Nizamie
Organizational Affiliation
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25255169
Citation
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.
Results Reference
derived
Learn more about this trial
Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence
We'll reach out to this number within 24 hrs