Alcohol Use Disorder
Conditions
Keywords
Alcohol use disorder
Brief summary
The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder.
Detailed description
This study employs a randomized, double-blind design to investigate the emerging non-invasive deep brain stimulation modality of temporal interference stimulation (tTIS) targeted at the amygdala, aiming to validate the efficacy and feasibility of non-invasively modulating the amygdala for the treatment of patients with alcohol use disorder (AUD). During the intervention phase, all participants will be randomly assigned to receive either active stimulation or sham stimulation. The localization of the amygdala will be modeled based on individual brain imaging data for each participant. Clinical characteristics, electroencephalography (EEG) and magnetic resonance imaging (MRI) data will be collected from all patients at baseline and post-intervention. In addition, follow-up assessments of alcohol consumption will be conducted for all participants after the intervention.
Interventions
DEVICEtTIS on Amygdala, 10 Hz
Through the transcranial electric stimulation device, the first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.010 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 10 Hz can be generated in the target area. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.
DEVICEtTIS on Amygdala, Sham
The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* aged 18 to 60 years old; * Meets the DSM-5 diagnostic criteria for alcohol use disorder; * Normal or corrected normal vision and hearing; * Able to cooperate in completing the questionnaire assessment and behavioral tests; * No metal implantation in the head, no history of neurological problems or head injury.
Exclusion criteria
* Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months; * serious physical or neurological illness, a diagnosis of any other psychiatric disorder under DSM-5 criteria (except for nicotine use disorder); Other psychoactive substance abuse or dependence in the last 5 years (except nicotine). * any contraindications to transcranial electrical stimulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Craving assessed by Visual Analog Scale | Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period. | evaluate all participants' craving for for alcohol assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 100, and higher values represent high level of craving. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who relapse | At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital. | Follow up with patients after discharge, evaluate number of participants who relapse. |
| Depression status assessed by Patient Health Questionnaire-9(PHQ-9) | Baseline and 7 days after intervention | evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression. |
| Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7) | Baseline and 7 days after intervention | evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). GAD-7 range from 0 to 21, and higher values represent more severe level of anxiety. |
| Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm | Baseline and 7 days after intervention | assessed by the natural reward/alcohol choice preference paradigm under simultaneous electroencephalogram and electrocardiogram recording. |
| Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm | Baseline and 7 days after intervention | assessed by the negative reward prediction error E-prime paradigm under simultaneous electroencephalogram and electrocardiogram recording. |
| Emotional states assessed using the Depression Anxiety Stress Scales (DASS). | Baseline and 7 days after intervention | Depression, anxiety and stress levels of all participants were assessed using the Depression Anxiety Stress Scales (DASS). Scores on the DASS ranged from 0 to 63, with higher scores indicating more severe levels of depression, anxiety and stress. |
| levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS) | Baseline and 7 days after intervention | evaluate all participants' levels of positive and negative affect by Positive and Negative Affect Schedule (PANAS).The PANAS consists of two dimensions: positive affect and negative affect, with scores ranging from 10 to 50 for each dimension, with higher scores indicating stronger positive or negative affect. |
| perceived stress assessed by Perceived Stress Scale (PSS) | Baseline and 7 days after intervention | evaluate all participants' the level of perceived stress by the Perceived Stress Scale (PSS). PSS range from 0 to 40, and higher values represent higher level of perceived stress. |
| Functional connectivity assessed by MRI | Baseline and 7 days after intervention | evaluate all participants' functional connectivity in the brain by MRI |
| Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ） | Baseline and 7 days after intervention | evaluate all participants' the Cognitive emotion regulation strategies by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ consists of four subscales, with scores for each subscale ranging from 4 to 20. Higher scores indicate more frequent use of the corresponding cognitive emotion regulation strategy. |
Countries
China
Contacts
CONTACTTianzhen Chen, M.D, Ph.D
PRINCIPAL_INVESTIGATORMin Zhao, M.D, Ph.D
Shanghai Mental Health Center
Outcome results
None listed