Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

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.
    

Intervention name(s): Magstim Rapid® (rTMS)
Intervention type(s): Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol dependence; Craving; rTMS; Dorsolateral prefrontal cortex