A Study of the Effectiveness of Direct Current Stimulation for Alcohol Use Disorders

Alcohol Use Disorder Clinical Trial

Official title:

Transcranial Direct Current Stimulation of the Bilateral Dorsolateral Prefrontal Cortex for Alcohol Use Disorders: A Randomised, Sham-controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04135599
• Other study ID #: NZhong-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2019
• Source: Shanghai Mental Health Center
• Contact: Na Zhong, Doctor
• Phone: 008613671644472
• Email: winco917[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving in drug addiction.

Objective:In this study, the investigators employed real and sham tDCS of the bilateral dorsolateral prefrontal cortex (DLPFC) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fMRI).

Methods: The investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5mA tDCS to the bilateral DLPFC (anodal right/cathodal left). The neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected.

The investigators hypothesized that tDCS stimulating the DLPFC decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:(1)Clinical diagnosis of severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); (2)Must be able to look and hear; (3) Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score less than 10.

Exclusion Criteria:(1) Clinical diagnosis of substance use disorder other than an alcohol or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5);(2) Severe brain injury, stroke, seizure, epilepsy or other major neurological diseases ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for fMRI scanning.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease

Intervention

Device:
• transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline functional magnetic resonance imaging at 2 weeks	Stop signal task during fMRI scanning (Philips Ingenia 3.0T MRI).	Two weeks
Secondary	cue-induced craving	Participants were instructed to pay close attention to real alcoholic beverages and rate their level of craving after smelling and recalling the last time they engaged in alcohol use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for alcohol".	Two weeks
Secondary	Cognitive function	Chinese version of the CogState Battery was used to assess cognitive function. We selected two tasks: Two back task (working memory) and Identification task (attention) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task and the speed in Identification task are our focus.	Two weeks
Secondary	Relapse	Meet the criteria for mild to severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)	One month after discharge from the hospital