Transcranial Magnetic Stimulation in Alcohol Use Disorder
Alcohol Dependence
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria:
- At least two days a week of excessive alcohol consumption during the month prior to screening;
- Ability to provide informed consent;
- A Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal score < 10;
- Willingness to abstain from or substantially reduce alcohol consumption;
- Permanent residence.
Exclusion Criteria:
- Clinically significant psychiatric diseases;
- Past or current abuse or dependence on substances other than alcohol or nicotine;
- Neurological disorders;
- Unstable medical conditions;
- Pacemakers, implanted metallic pumps, metal implant;
- History of complicated withdrawal symptoms;
- Current use of psychoactive drugs;
- Epilepsy;
- Current use of anticonvulsants, insulin or oral hypoglycemic agents;
- Positive urine toxicological screening;
- Pregnancy;
- Participation in other clinical trial in the last 60 days;
- Involvement in a compulsory medical treatment or pending criminal proceedings.
Sites / Locations
- Catholic University of Rome
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Deep rTMS
Placebo
The intervention consisted of deep rTMS of dorsolateral prefrontal cortex through the Brainsway Deep TMS System using an H-shaped coil . The motor threshold was measured by delivering a single pulse to the motor cortex. The site of stimulation was located 5.5 cm anterior to the point at which maximum stimulation of the abductor pollicis brevis muscle was reached. Each patient received a total of 12 rTMS sessions (three sessions per week): 20 trains per session at an intensity of 100% of the motor threshold, 50 pulses per train at a frequency of 10 Hertz, an inter-train interval of 15 seconds.
The sham stimulation consisted of rTMS sessions without an effective instrument operation.