tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

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

Intervention / Treatment
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* Device: Transcranial Random Noise Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tRNS over Anterior Cingulate<br>Dual Pathology (Substance Use Disorder plus another psychiatric trait) 75 patients with diagnosed SUDs plus another psychiatric disorder will be receive tRNS in the disease-specific Anterior Cingulate Cortex (ACC), be studied blindly to evaluate the craving reduction after 35 tRNS sessions. | Device: Transcranial Random Noise Stimulation<br>* Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas<br>* Other names: tRNS, tES;|
| Experimental: tRNS applied over DLPFC<br>Dual Pathology (Substance Use Disorder plus another psychiatric trait) 75 patients with diagnosed SUDs plus another psychiatric disorder will be receive tRNS in the dorso-lateral-prefrontal-cortex (DLPFC), be studied blindly to evaluate the craving reduction after 35 tRNS sessions. | Device: Transcranial Random Noise Stimulation<br>* Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas<br>* Other names: tRNS, tES;|
| Sham Comparator: Sham Group<br>75 patients will be receive tRNS sham 35 sessions. | Device: Transcranial Random Noise Stimulation<br>* Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas<br>* Other names: tRNS, tES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMEN Questionnarie | 100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system | 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 ] | Following patients during 3 months after Brain noninvasive estimulation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Schizophrenia, Bipolar disorder, Personality disorder