Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tTIS on Amygdala, 10 Hz, tTIS on Amygdala, Sham.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: 18 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder
Overview
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
- Device tTIS 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 - Device tTIS 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.
Primary outcome measures
- 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.]
Secondary outcome measures (10)
- Number of participants who relapse [Time frame: At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.]
- Depression status assessed by Patient Health Questionnaire-9(PHQ-9) [Time frame: Baseline and 7 days after intervention]
- Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7) [Time frame: Baseline and 7 days after intervention]
- Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm [Time frame: Baseline and 7 days after intervention]
- Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm [Time frame: Baseline and 7 days after intervention]
- Emotional states assessed using the Depression Anxiety Stress Scales (DASS). [Time frame: Baseline and 7 days after intervention]
- levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS) [Time frame: Baseline and 7 days after intervention]
- perceived stress assessed by Perceived Stress Scale (PSS) [Time frame: Baseline and 7 days after intervention]
- Functional connectivity assessed by MRI [Time frame: Baseline and 7 days after intervention]
- Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ） [Time frame: Baseline and 7 days after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT07472673 · MZhao-026 · 2021ZD0202105 · 82571704