search
Back to results

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

Primary Purpose

Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcranial Random Noise Stimulation
Sponsored by
Spanish Foundation for Neurometrics Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder focused on measuring Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Schizophrenia, Bipolar disorder, Personality disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Slow Environment Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tRNS over Anterior Cingulate

tRNS applied over DLPFC

Sham Group

Arm Description

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.

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.

75 patients will be receive tRNS sham 35 sessions.

Outcomes

Primary Outcome Measures

AMEN Questionnarie
100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system
Emotional Visual Event Related Potentials
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)
The CAGE-AID is a sensitive screen for alcohol and drug problems.

Full Information

First Posted
June 10, 2013
Last Updated
July 30, 2023
Sponsor
Spanish Foundation for Neurometrics Development
Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT01876524
Brief Title
tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
Acronym
tRND&SUDs
Official Title
Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Foundation for Neurometrics Development
Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Bipolar Disorder, Schizophrenia, Personality Disorder
Keywords
Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Schizophrenia, Bipolar disorder, Personality disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tRNS over Anterior Cingulate
Arm Type
Experimental
Arm Description
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.
Arm Title
tRNS applied over DLPFC
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
75 patients will be receive tRNS sham 35 sessions.
Intervention Type
Device
Intervention Name(s)
Transcranial Random Noise Stimulation
Other Intervention Name(s)
tRNS, tES
Intervention Description
Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
Primary Outcome Measure Information:
Title
AMEN Questionnarie
Description
100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system
Time Frame
Following patients during 3 months after Brain noninvasive estimulation
Title
Emotional Visual Event Related Potentials
Description
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 ]
Time Frame
Following patients during 3 months after Brain noninvasive estimulation
Secondary Outcome Measure Information:
Title
CAGE Adapted to Include Drugs (CAGE-AID)
Description
The CAGE-AID is a sensitive screen for alcohol and drug problems.
Time Frame
Following 3 months after tRNS brain stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 Pregnant
Facility Information:
Facility Name
Slow Environment Foundation
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30310
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
10522446
Citation
Soria Aledo V, Aguilar Domingo M, Garcia Cuadrado J, Carrasco Prats M, Gonzalez Martinez 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. No abstract available. Spanish.
Results Reference
result

Learn more about this trial

tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

We'll reach out to this number within 24 hrs