About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
tTIS on Amygdala, 10 Hz
DeviceThrough 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.
tTIS on Amygdala, Sham
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change of Craving assessed by Visual Analog Scale
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
Follow up with patients after discharge, evaluate number of participants who relapse.
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
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)
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
assessed by the natural reward/alcohol choice preference paradigm under simultaneous electroencephalogram and electrocardiogram recording.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: