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

This study has been completed.
Sponsor:
Information provided by:
Central Institute of Psychiatry, Ranchi, India
ClinicalTrials.gov Identifier:
NCT01093716
First received: March 22, 2010
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

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 Intervention
Alcohol Dependence
Device: Magstim Rapid® (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Central Institute of Psychiatry, Ranchi, India:

Primary Outcome Measures:
  • Craving [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Alcohol Craving Questionnaire (ACQ-NOW) total score


Secondary Outcome Measures:
  • Craving [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Alcohol Craving Questionnaire (ACQ-NOW) factor scores


Enrollment: 22
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093716

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

No publications provided

Responsible Party: Prof. S. Haque Nizamie, Central Institute of Psychiatry, Ranchi, India
ClinicalTrials.gov Identifier: NCT01093716     History of Changes
Other Study ID Numbers: ADSTMS2010
Study First Received: March 22, 2010
Last Updated: March 25, 2010
Health Authority: India: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014