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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
Central Institute of Psychiatry, Ranchi, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Craving, rTMS, Dorsolateral prefrontal cortex

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

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

    First Posted
    March 22, 2010
    Last Updated
    March 25, 2010
    Sponsor
    Central Institute of Psychiatry, Ranchi, India
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    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

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