Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of Craving assessed by Visual Analog Scale
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
tTIS stimulation group
The two high-frequency electric fields of the temporal interference (TI) device are set at distinct frequencies (2 kHz and 2.010 kHz), thereby generating a low-frequency electric field (10 Hz) specifically targeted at the amygdala.
For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session.
Intervention: tTIS on Amygdala, 10 Hz (Device)
Sham tTIS stimulation group
The two high-frequency electric fields of the temporal interference (TI) device are set at the same frequencies (2 kHz and 2 kHz), which are specifically targeted at the amygdala. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session.
Intervention: tTIS on Amygdala, Sham (Device)
Outcomes
Primary Outcomes
Change of Craving assessed by Visual Analog Scale
Time Frame: 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 Outcomes
- Number of participants who relapse(At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.)
- Depression status assessed by Patient Health Questionnaire-9(PHQ-9)(Baseline and 7 days after intervention)
- Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)(Baseline and 7 days after intervention)
- Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm(Baseline and 7 days after intervention)
- Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm(Baseline and 7 days after intervention)
- Emotional states assessed using the Depression Anxiety Stress Scales (DASS).(Baseline and 7 days after intervention)
- levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS)(Baseline and 7 days after intervention)
- perceived stress assessed by Perceived Stress Scale (PSS)(Baseline and 7 days after intervention)
- Functional connectivity assessed by MRI(Baseline and 7 days after intervention)
- Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ）(Baseline and 7 days after intervention)