tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial Random Noise Stimulation

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Transcranial Random Noise Stimulation

Intervention Type DEVICE

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

Sham Group

75 patients will be receive tRNS sham 35 sessions.

Group Type SHAM_COMPARATOR

Transcranial Random Noise Stimulation

Intervention Type DEVICE

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

Interventions

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Transcranial Random Noise Stimulation

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

Intervention Type DEVICE

Other Intervention Names

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tRNS, tES

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No