NCT03058276

New Therapeutic Strategies for Inhibitory Control in Alcoholism

New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Hospital Universitario 12 de Octubre · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.

Detailed description

The main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified Stop signal task): a behavioral treatment based on Retrieval-Extinction Learning, through the AAT (Alcohol Approach Avoiding Task) and a treatment based on the neuromodulation of prefrontal cortex through the rTMS (repetitive transcraneal magnetic stimulation) technique. To carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (UPPS) and behvavioral impulsivity (Stop signal task), along with biological measures for polymorphism determinations. Alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for Retrieval-Extinction Learning with AAT and 2:1 (double for the effective technique comparing to placebo/control) for rTMS): Group 1 (N=30): exposure to an alcohol-related video followed by AAT; Group 2 (N=30): neutral-content video followed by AAT; Group 4 (30): active stimulation rTMS (10 Hz) ; Group 4 (N=15): placebo stimulation SAM.

Conditions

• Alcoholism

Interventions

Type	Name	Description
BEHAVIORAL	Retrieval-Extinction Learning	The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.
OTHER	rTMS	Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with Magstim Rapid coil. rTMS is performed at 10 Hz, during 4.9 seconds,for each set of stimuli (20), with a interval between sets of 30 seconds.
OTHER	SAM	Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with SAM coil.

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2017-02-20
• Last updated: 2023-03-08

Locations

1 site across 1 country: Spain