tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients

Schizophrenia Clinical Trial

— tRND&SUDs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876524
• Other study ID #: tRNS01072013
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2023
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Bipolar Disorder
• Hyperkinesis
• Personality Disorder
• Personality Disorders
• Schizophrenia
• Substance Use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Spain	Slow Environment Foundation	Cartagena	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Foundation for Neurometrics Development	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMEN Questionnarie	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
Primary	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 ]	Following patients during 3 months after Brain noninvasive estimulation
Secondary	CAGE Adapted to Include Drugs (CAGE-AID)	The CAGE-AID is a sensitive screen for alcohol and drug problems.	Following 3 months after tRNS brain stimulation