Transcranial Temporal Interference Stimulation Targeted of the Striatum as an Intervention for Methamphetamine Use Disorder Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of Craving
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Temporal Interference Stimulation Group
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.
Intervention: Temporal Interference Stimulation (Device)
Control Group
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.
Intervention: Shame (Device)
Outcomes
Primary Outcomes
Change of Craving
Time Frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
Secondary Outcomes
- Drug Use(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- impulsivity(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- Decision-making Preferences and Delay of Gratification(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- Changes in Reward Learning(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- sensitivity to reward and punishment(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- emotional states(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- emotional state(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- sleep quality(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment)
- EEG(baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment)