- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876524
tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients (tRND&SUDs)
Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Murcia
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Cartagena, Murcia, Spain, 30310
- Slow Environment Foundation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
Other Names:
|
|
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.
|
Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
Other Names:
|
|
Sham Comparator: Sham Group
75 patients will be receive tRNS sham 35 sessions.
|
Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
Other Names:
|
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
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Following patients during 3 months after Brain noninvasive estimulation
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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
Investigators
- Principal Investigator: Moises Aguilar-Domingo, PhD, Spanish Foundation for Neurometrics Development
Publications and helpful links
General Publications
- Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
- Manni C, Cipollone G, Pallucchini A, Maremmani AGI, Perugi G, Maremmani I. Remarkable Reduction of Cocaine Use in Dual Disorder (Adult Attention Deficit Hyperactive Disorder/Cocaine Use Disorder) Patients Treated with Medications for ADHD. Int J Environ Res Public Health. 2019 Oct 15;16(20):3911. doi: 10.3390/ijerph16203911.
- Allenby C, Falcone M, Bernardo L, Wileyto EP, Rostain A, Ramsay JR, Lerman C, Loughead J. Transcranial direct current brain stimulation decreases impulsivity in ADHD. Brain Stimul. 2018 Sep-Oct;11(5):974-981. doi: 10.1016/j.brs.2018.04.016. Epub 2018 Apr 23.
- Cubillo A, Halari R, Smith A, Taylor E, Rubia K. A review of fronto-striatal and fronto-cortical brain abnormalities in children and adults with Attention Deficit Hyperactivity Disorder (ADHD) and new evidence for dysfunction in adults with ADHD during motivation and attention. Cortex. 2012 Feb;48(2):194-215. doi: 10.1016/j.cortex.2011.04.007. Epub 2011 Apr 27.
- Fonteneau C, Redoute J, Haesebaert F, Le Bars D, Costes N, Suaud-Chagny MF, Brunelin J. Frontal Transcranial Direct Current Stimulation Induces Dopamine Release in the Ventral Striatum in Human. Cereb Cortex. 2018 Jul 1;28(7):2636-2646. doi: 10.1093/cercor/bhy093.
- Westwood SJ, Criaud M, Lam SL, Lukito S, Wallace-Hanlon S, Kowalczyk OS, Kostara A, Mathew J, Agbedjro D, Wexler BE, Cohen Kadosh R, Asherson P, Rubia K. Transcranial direct current stimulation (tDCS) combined with cognitive training in adolescent boys with ADHD: a double-blind, randomised, sham-controlled trial. Psychol Med. 2023 Jan;53(2):497-512. doi: 10.1017/S0033291721001859. Epub 2021 Jul 6.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Chemically-Induced Disorders
- Mood Disorders
- Neurodevelopmental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Schizophrenia
- Bipolar Disorder
- Substance-Related Disorders
- Attention Deficit Disorder with Hyperactivity
- Personality Disorders
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
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.
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