Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093716
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : March 26, 2010
Information provided by:
Central Institute of Psychiatry, Ranchi, India

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Device: Magstim Rapid® (rTMS) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Anti-craving Efficacy of Right and Left Prefrontal High Frequency rTMS in Alcohol Dependence: a Randomized Double-blind Study
Study Start Date : August 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rTMS
Compare the change in craving parameters following high frequency rTMS stimulation of right and left DLPFC in patients with alcohol dependence
Device: Magstim Rapid® (rTMS)
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 Measures :
  1. Craving [ Time Frame: 2 weeks ]
    Alcohol Craving Questionnaire (ACQ-NOW) total score

Secondary Outcome Measures :
  1. Craving [ Time Frame: 2 weeks ]
    Alcohol Craving Questionnaire (ACQ-NOW) factor scores

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of Alcohol dependence syndrome according to ICD-10 DCR,
  2. Male patients aged between 18-60 years,
  3. Patients with CIWA-Ar scores ≤10,
  4. Right handed, normotensive patients,
  5. Patients giving written informed consent.

Exclusion Criteria:

  1. Comorbid psychiatric, major medical or neurological disorders,
  2. History of withdrawal seizures, delirium tremens or significant head injury,
  3. Subjects with pacemaker or metal in any part of the body excluding the mouth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01093716

Sponsors and Collaborators
Central Institute of Psychiatry, Ranchi, India
Principal Investigator: S Haque Nizamie Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. S. Haque Nizamie, Central Institute of Psychiatry, Ranchi, India Identifier: NCT01093716     History of Changes
Other Study ID Numbers: ADSTMS2010
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010

Keywords provided by Central Institute of Psychiatry, Ranchi, India:
Alcohol dependence
Dorsolateral prefrontal cortex

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs