tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients (tRND&SUDs)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Substance Use Disorder; Attention Deficit Disorder With Hyperactivity; Bipolar Disorder; Schizophrenia; Personality Disorder	Device: Transcranial Random Noise Stimulation	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	225 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
Study Start Date :	July 2013
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: tRNS over Anterior Cingulate; 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; Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas; Other Name: tRNS, tES
Experimental: tRNS applied over DLPFC; 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; Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas; Other Name: tRNS, tES
Sham Comparator: Sham Group; 75 patients will be receive tRNS sham 35 sessions.	Device: Transcranial Random Noise Stimulation; Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas; Other Name: tRNS, tES

Outcome Measures

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Primary Outcome Measures :

1. AMEN Questionnarie [ Time Frame: 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
2. Emotional Visual Event Related Potentials [ Time Frame: 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
Slow Environment Foundation
Cartagena, Murcia, Spain, 30310

Sponsors and Collaborators

Spanish Foundation for Neurometrics Development

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Neurometrics S.L.

Investigators

Principal Investigator:	Moises Aguilar-Domingo, PhD	Spanish Foundation for Neurometrics Development

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Neurometrics 

Spanish Foundation for Neurometrics Development 

Slow Environment Foundation 

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia 

Publications of Results:

Soria Aledo V, Aguilar Domingo M, García Cuadrado J, Carrasco Prats M, González Martínez P. [Spontaneous rupture of the spleen: a rare form of onset of non-Hodgkin's lymphoma]. Rev Clin Esp. 1999 Aug;199(8):552-3. Spanish.

Responsible Party:	Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:	NCT01876524 History of Changes
Other Study ID Numbers:	tRNS01072013
First Posted:	June 12, 2013
Last Update Posted:	October 17, 2014
Last Verified:	October 2014

Keywords provided by Spanish Foundation for Neurometrics Development:

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

Additional relevant MeSH terms:

Disease; Schizophrenia; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Personality Disorders; Substance-Related Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders	Mental Disorders; Bipolar and Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Chemically-Induced Disorders