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

July 30, 2023 updated by: Spanish Foundation for Neurometrics Development

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • Cartagena, Murcia, Spain, 30310
        • Slow Environment Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • tRNS, tES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Following patients during 3 months after Brain noninvasive estimulation
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 ]
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)
Time Frame: Following 3 months after tRNS brain stimulation
The CAGE-AID is a sensitive screen for alcohol and drug problems.
Following 3 months after tRNS brain stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Foundation for Neurometrics Development

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimated)

June 12, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tRNS01072013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Transcranial Random Noise Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe