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

Spanish Foundation for Neurometrics Development

Status: Completed

Conditions: Personality Disorder; Schizophrenia; Bipolar Disorder; Attention Deficit Disorder With Hyperactivity; Substance Use Disorder

Treatments: Device: Transcranial Random Noise Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01876524

tRNS01072013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

tRNS over Anterior Cingulate

Experimental group

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.

Treatment:

Device: Transcranial Random Noise Stimulation

tRNS applied over DLPFC

Experimental group

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.

Treatment:

Device: Transcranial Random Noise Stimulation

Sham Group

Sham Comparator group

Description:

75 patients will be receive tRNS sham 35 sessions.

Treatment:

Device: Transcranial Random Noise Stimulation