tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients (tRND&SUDs)
This study has been completed.
Sponsor:
Spanish Foundation for Neurometrics Development
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
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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:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Attention Deficit Hyperactivity Disorder
Bipolar Disorder
Noise
Personality Disorders
Schizophrenia
U.S. FDA Resources
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 (Adult) |
| 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
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:
|
Disease Schizophrenia Bipolar Disorder Attention Deficit Disorder with Hyperactivity Hyperkinesis Personality Disorders Substance-Related Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders |
Mental Disorders Bipolar and Related Disorders Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Chemically-Induced Disorders |
ClinicalTrials.gov processed this record on September 26, 2016