tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Not Applicable

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity; Substance Use Disorder; Bipolar Disorder; Schizophrenia; Personality Disorder

• Registration Number: NCT01876524
• Lead Sponsor: Spanish Foundation for Neurometrics Development

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Study Start: 2013-07
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emotional Visual Event Related Potentials	Following patients during 3 months after Brain noninvasive estimulation	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 \[ Time Frame: brainwaves patterns following an array of visual stimuli (human faces) during a 22 min. examination \]
AMEN Questionnarie	Following patients during 3 months after Brain noninvasive estimulation	100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system

Secondary Outcome Measures

Name	Time	Method
CAGE Adapted to Include Drugs (CAGE-AID)	Following 3 months after tRNS brain stimulation	The CAGE-AID is a sensitive screen for alcohol and drug problems.

Trial Locations

Locations (1)

Slow Environment Foundation; 🇪🇸 Cartagena, Murcia, Spain