Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Mental Health Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Temporal Interference Stimulation

    Device

    Each 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

    Device

    The 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

50 Participants
are divided into 2 treatment groups
Group A: Temporal Interference Stimulation GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Craving

Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.

Time frame
baseline, 1 day after treatment, 1 month after treatment

Secondary outcomes

1

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.

Time frame
baseline, 1 day after treatment, 1 month after treatment
2

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.

Time frame
baseline, 1 day after treatment, 1 month after treatment
3

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.

Time frame
baseline, 1 day after treatment, 1 month after treatment
4

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.

Time frame
baseline, 1 day after treatment, 1 month after treatment

Other outcomes

Sponsors and contacts

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