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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01876524
Other study ID # tRNS01072013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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