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tTIS Targeted of the Striatum as an Intervention for MUD Patients

Transcranial Temporal Interference Stimulation Targeted of the Striatum as an Intervention for Methamphetamine Use Disorder Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07479771
Enrollment
53
Registered
2026-03-18
Start date
2026-03-26
Completion date
2026-08-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amphetamine Use Disorders

Keywords

Amphetamine-type stimulants, temporal interference stimulation

Brief summary

Targeted temporal interference stimulation (tTIS) of the caudate nucleus can modulate the abnormal electrophysiological activity in individuals with methamphetamine use disorder (MUD), thereby improving their impaired reward-learning behaviors and reducing drug craving.

Detailed description

This project will recruit MUD patients. A 5-day intervention protocol of real or sham tTIS targeting the caudate nucleus will be employed. Before and after intervention, drug craving anddrug use and other questionnaire as well as stop-signal tasks, and reward-learning tasks will be used to evaluate its therapeutic efficacy on clinical craving and the underlying neural mechanisms.

Interventions

DEVICETemporal Interference Stimulation

The stimulation duration are 30 minutes per session, administered twice daily for 5 consecutive days.

DEVICEShame

The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 6 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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Cravingbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentVisual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.

Secondary

MeasureTime frameDescription
Drug Usebaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentOCDUSE scale
impulsivitybaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentThis study employed the BIS-11 Impulsiveness Scale
Changes in Reward Learningbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentReward LearningTask
Decision-making Preferences and Delay of Gratificationbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentdelay discounting task
sensitivity to reward and punishmentbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentthe Sensitivity to Punishment and Sensitivity to Reward Questionnaire, the Cognitive Flexibility Scale, the Behavioral Inhibition/Activation System Scale
emotional statesbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentthe BDI Depression Inventory
emotional statebaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentthe BAI Anxiety Inventory
sleep qualitybaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatmentthe PSQI Sleep Quality Index
EEGbaseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatmentsource power of each frequency band

Countries

China

Contacts

STUDY_CHAIRMin Zhao, PhD

Shanghai Mental Health Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026