tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Spanish Foundation for Neurometrics Development225 enrolled

Overview

The purpose of this study is to study the efficacy and security of noninvasive brain stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.

Background: There is an intimate relationship between addictive behaviors and other mental disorders, proven by clinical practice and many epidemiological studies, genetic and neuroscience. This gives risk to the diagnosis of Dual Pathology: an addiction and another mental disorder. Functional neuroimaging studies have shown that anterior cingulate cortex is associated with substance´s dependence and craving. Transcranial random noise stimulation (tRNS) stimulates parts of the brain and can change it´s activity. Researchers are interested in reduce cravings for substance dependence on patients with Dual Pathology using tRNS in anterior cingulate cortex. Aims: To determine whether tRNS in anterior cingulate cortex can reduce craving over Dual Pathology patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Substance Use Disorder Attention Deficit Disorder With Hyperactivity Bipolar Disorder Schizophrenia Personality Disorder

Interventions

Transcranial Random Noise StimulationDEVICE

Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \> 18 years old and less than 60 years * Best-practice diagnosed Dual Pathology * Diagnosed since at least two years prior to enrollment. * Abuse more than 2 Substances ExclusionC riteria: * Serious visual and hearing loss * Brain injury following cranial trauma * Other neurological disorders like Parkinson, ME, headache, etc. * Birth trauma * Mental retardation * Pregnant

Locations (1)

Slow Environment Foundation

Cartagena, Murcia, Spain

Outcomes

Primary Outcomes

AMEN Questionnarie

100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system

Time frame: Following patients during 3 months after Brain noninvasive estimulation

Emotional Visual Event Related Potentials

Emotional Visual Event Related Potentials responses (time courses and topographies) and ICA components related with them, identified by Mitsar 201M EEG Amplifier using EEGLab software \[ Time Frame: brainwaves patterns following an array of visual stimuli (human faces) during a 22 min. examination \]

Time frame: Following patients during 3 months after Brain noninvasive estimulation

Secondary Outcomes

CAGE Adapted to Include Drugs (CAGE-AID)

The CAGE-AID is a sensitive screen for alcohol and drug problems.

Time frame: Following 3 months after tRNS brain stimulation

Data from ClinicalTrials.gov

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