Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorShanghai Mental Health Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • tTIS on Amygdala, 10 Hz

    Device

    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.

  • tTIS on Amygdala, Sham

    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 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

60 Participants
are divided into 2 treatment groups
Group A: tTIS stimulation groupExperimental treatment 1 intervention
Group B: Sham tTIS stimulation groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.

Secondary outcomes

1

Number of participants who relapse

Follow up with patients after discharge, evaluate number of participants who relapse.

Time frame
At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.
2

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.

Time frame
Baseline and 7 days after intervention
3

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.

Time frame
Baseline and 7 days after intervention
4

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.

Time frame
Baseline and 7 days after intervention

Other outcomes

Sponsors and contacts

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