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Clinical Trials/NCT01876524
NCT01876524
Completed
Not Applicable

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

Spanish Foundation for Neurometrics Development1 site in 1 country225 target enrollmentJuly 1, 2013

Overview

Phase
Not Applicable
Intervention
Transcranial Random Noise Stimulation
Conditions
Substance Use Disorder
Sponsor
Spanish Foundation for Neurometrics Development
Enrollment
225
Locations
1
Primary Endpoint
Emotional Visual Event Related Potentials
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2013
End Date
September 1, 2014
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Spanish Foundation for Neurometrics Development
Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Transcranial Random Noise Stimulation

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.

Intervention: Transcranial Random Noise Stimulation

Sham Group

75 patients will be receive tRNS sham 35 sessions.

Intervention: Transcranial Random Noise Stimulation

Outcomes

Primary Outcomes

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 \[ Time Frame: brainwaves patterns following an array of visual stimuli (human faces) during a 22 min. examination \]

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

Secondary Outcomes

  • CAGE Adapted to Include Drugs (CAGE-AID)(Following 3 months after tRNS brain stimulation)

Study Sites (1)

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