tTIS Targeted of the Striatum as an Intervention for MUD Patients

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Amphetamine Use Disorders

Treatments: Device: Shame; Device: Temporal Interference Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07479771

MZhao-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Temporal Interference Stimulation Group

Experimental group

Description:

The first pair of electrodes continuously delivers a current at a frequency of f1 = 1 kHz, while the second pair delivers a current at f2 = 1.130 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.

Treatment:

Device: Temporal Interference Stimulation

Control Group

Sham Comparator group

Description:

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 no actual current being delivered during the stimulation.

Treatment:

Device: Shame