Clinical trial NCT01093716: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Craving
rTMS
Dorsolateral prefrontal cortex
Lead sponsor: Central Institute of Psychiatry, Ranchi, India
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Craving
timeFrame: 2 weeks
Secondary outcomes:
measure: Craving
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India
name: S Haque Nizamie
role: PRINCIPAL_INVESTIGATOR
References:
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.