Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients
2026년 8월 31일 업데이트: Shanghai Mental Health Center
Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
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.
연구 개요
상세 설명
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Min Zhao, PhD
- 전화번호: 64387250
- 이메일: drminzhao@gmail.com
연구 연락처 백업
- 이름: Tianzhen Chen, PhD
- 이메일: vomchan@hotmail.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200030
- Shanghai Mental Health Center
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연락하다:
- Min Zhao, Phd
- 전화번호: 64387250 18017311005
- 이메일: drminzhao@smhc.org.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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가짜 비교기: 대조군
자극 파라미터—빈도, 전류 강도, 지속 시간을 포함하여—는 활성 그룹과 동일합니다.
그러나 기기에서 샴 자극 모드가 활성화되어, 자극 동안 실제 전류가 전달되지 않습니다.
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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.
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실험적: Temporal Interference Stimulation Group
The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz.
Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of Craving
기간: baseline, 1 day after treatment, 1 month after treatment
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Visual Analog Scale, range0-100 point.
the higher the score, the more one wants drugs.
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baseline, 1 day after treatment, 1 month after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Obsessive-Compulsive Drug Use Scale score
기간: baseline, 1 day after treatment, 1 month after treatment
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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.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Impulsive System score
기간: baseline, 1 day after treatment, 1 month after treatment
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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.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Control System score
기간: baseline, 1 day after treatment, 1 month after treatment
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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.
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baseline, 1 day after treatment, 1 month after treatment
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Stop Single Task
기간: baseline, 1 day after treatment, 1 month after treatment
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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.
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baseline, 1 day after treatment, 1 month after treatment
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EEG ERP amplitude during the Stop-Signal Task
기간: baseline, 1 day after treatment, 1 month after treatment
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The mean amplitude of the stop-related event-related potential and functional connection will be measured in microvolts over frontocentral electrodes within the prespecified post-stimulus time window.
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baseline, 1 day after treatment, 1 month after treatment
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Decision-making Preferences and Delay of Gratification
기간: baseline, 1 day after treatment, 1 month after treatment
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delay discounting task,Delay of gratification will be assessed using a computerised delay-discounting task in which participants choose between smaller immediate rewards and larger delayed rewards.
The discounting-rate parameter, k, will be estimated from participants' choices.
A higher k value indicates steeper delay discounting, a stronger preference for immediate rewards, and a lower ability to delay gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Changes in Reward Learning
기간: baseline, 1 day after treatment, 1 month after treatment
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Reward learning will be assessed using a computerised reinforcement-learning task.
A computational reinforcement-learning model will be fitted to participants' trial-by-trial choices.
The learning-rate parameter, alpha, ranges from 0 to 1 and represents the extent to which recent feedback is used to update expected values.
Higher values indicate greater updating in response to recent feedback.
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baseline, 1 day after treatment, 1 month after treatment
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sensitivity to reward and punishment
기간: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to punishment will be assessed using the Sensitivity to Punishment subscale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ).
The subscale contains 24 dichotomous items scored 0 or 1, producing a score ranging from 0 to 24.
Higher scores indicate greater sensitivity to punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Behavioral Inhibition/Activation System Scale
기간: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to anticipated punishment will be assessed using the 7-item Behavioural Inhibition System subscale of the Behavioural Inhibition System/Behavioural Activation System Scales.
Each item is rated from 1 to 4, producing a score ranging from 7 to 28.
Higher scores indicate greater behavioural inhibition and sensitivity to anticipated punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Beck Depression Inventory-II score
기간: baseline, 1 day after treatment, 1 month after treatment
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Depressive symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II).
The inventory consists of 21 items rated from 0 to 3, producing a total score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
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baseline, 1 day after treatment, 1 month after treatment
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Drug-cue Flanker task
기간: baseline, 1 day after treatment, 1 month after treatment
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Attentional interference from methamphetamine-related cues will be assessed using a computerised drug-cue Flanker task.
The drug-cue attentional interference effect will be calculated as the difference in mean reaction time between trials containing methamphetamine-related cues and trials containing neutral cues, measured in milliseconds.
A larger positive value indicates greater attentional interference from methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG theta power
기간: baseline, 1 day after treatment, 1 month after treatment
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Theta-band power will be quantified within the prespecified frequency range, electrode region, and post-stimulus time window.
The cue-related theta effect will be calculated as the difference between methamphetamine-related and neutral cue conditions.
A larger value indicates a stronger theta-band response to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG P3 amplitude
기간: baseline, 1 day after treatment, 1 month after treatment
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Task-related electroencephalography will be recorded during the drug-cue Flanker task and the reward learning task.
The mean amplitude of the P3 event-related potential will be measured in microvolts within the prespecified electrode region and post-stimulus time window.
A larger positive difference indicates greater neural reactivity to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Min Zhao, PhD, Shanghai Mental Health Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2026년 10월 30일
연구 완료 (추정된)
2026년 11월 1일
연구 등록 날짜
최초 제출
2026년 7월 30일
QC 기준을 충족하는 최초 제출
2026년 8월 31일
처음 게시됨 (실제)
2026년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .