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

This study has been completed.
Sponsor:
Collaborators:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Neurometrics S.L.
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT01876524
First received: June 10, 2013
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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 Intervention
Substance Use Disorder
Attention Deficit Disorder With Hyperactivity
Bipolar Disorder
Schizophrenia
Personality Disorder
Device: Transcranial Random Noise Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Resource links provided by NLM:


Further study details as provided by Spanish Foundation for Neurometrics Development:

Primary Outcome Measures:
  • AMEN Questionnarie [ Time Frame: Following patients during 3 months after Brain noninvasive estimulation ] [ Designated as safety issue: No ]
    100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system

  • Emotional Visual Event Related Potentials [ Time Frame: Following patients during 3 months after Brain noninvasive estimulation ] [ Designated as safety issue: No ]
    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:
  • CAGE Adapted to Include Drugs (CAGE-AID) [ Time Frame: Following 3 months after tRNS brain stimulation ] [ Designated as safety issue: No ]
    The CAGE-AID is a sensitive screen for alcohol and drug problems.


Enrollment: 225
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876524

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

Additional Information:
Publications:
Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT01876524     History of Changes
Other Study ID Numbers: tRNS01072013
Study First Received: June 10, 2013
Last Updated: October 16, 2014
Health Authority: Spain: Ethics Committee

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:
Attention Deficit Disorder with Hyperactivity
Bipolar Disorder
Disease
Hyperkinesis
Personality Disorders
Schizophrenia
Substance-Related Disorders
Affective Disorders, Psychotic
Attention Deficit and Disruptive Behavior Disorders
Chemically-Induced Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014