About this trial
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control. Stimulation will be delivered in real time according to each patient's cue-induced response time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
Consent to actively cooperate in the completion of subsequent follow-up assessments.
Disqualifiers
Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
Severe organic diseases that might compromise study participation.
Trial design
Parallel
Treatments tested in this trial
Temporal Interference Stimulation
DeviceEach session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state. Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down. The intervention will be administered once daily for five consecutive days.
Shame
DeviceThe stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Change of Craving
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
Secondary outcomes
Obsessive-Compulsive Drug Use Scale score
Drug-related obsessive thoughts and compulsive behaviours will be assessed using the Obsessive-Compulsive Drug Use Scale (OCDUS). The scale consists of 14 items rated from 0 to 4, producing a total score ranging from 0 to 56. Higher scores indicate more severe drug-related obsessive thoughts, craving, and impaired control over drug use.
Dual-Mode of Self-Control Scale-Impulsive System score
Impulsive tendencies will be assessed using the Impulsive System subscale of the Dual-Mode of Self-Control Scale (DMSC-S). The subscale contains 12 items rated from 1 to 5, producing a total score ranging from 12 to 60. Higher scores indicate stronger impulsive-system tendencies, including greater impulsivity, distractibility, and preference for immediate gratification.
Dual-Mode of Self-Control Scale-Control System score
Self-control will be assessed using the Control System subscale of the Dual-Mode of Self-Control Scale (DMSC-S). The subscale contains 9 items rated from 1 to 5, producing a total score ranging from 9 to 45. Higher scores indicate stronger self-control, including better problem-solving and future-oriented planning.
Stop Single Task
Response inhibition will be assessed using the Stop-Signal Task. The primary behavioural parameter will be the reaction time and accuracy, measured in milliseconds. A longer stop-signal reaction time indicates poorer inhibitory control, whereas a shorter stop-signal reaction time indicates better inhibitory control.
Sponsors and contacts
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