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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04135599
Enrollment
40
Registered
2019-10-22
Start date
2019-10-31
Completion date
2020-04-30
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Brief 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.

Interventions

DEVICEtranscranial 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.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline functional magnetic resonance imaging at 2 weeksTwo weeksStop signal task during fMRI scanning (Philips Ingenia 3.0T MRI).

Secondary

MeasureTime frameDescription
cue-induced cravingTwo weeksParticipants 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 cravingand 100 mm representing most craving ever experienced for alcohol.
Cognitive functionTwo weeksChinese 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.
RelapseOne month after discharge from the hospitalMeet the criteria for mild to severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)

Contacts

Primary ContactNa Zhong, Doctor
winco917@hotmail.com008613671644472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026