Closed-loop tACS Modulation for the Core Clinical Features of Drug Addiction

Shanghai Mental Health Center

Status: Completed

Conditions: Amphetamine Use Disorders

Treatments: Device: Closed-loop tACS stimulation based on addiction-induced states

Study type: Interventional

Funder types: Other

Identifiers

NCT06454474

MZhao-016

Details and patient eligibility

About

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states

Full description

Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Enrollment: 21 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals aged between 18 and 45 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 severity of 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 tACS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Closed-loop tACS stimulation based on addiction-induced states

Experimental group

Description:

In the initial phase of this study, participants will be subjected to individual closed-loop tACS interventions for ten-days intervals. Concurrently, they will be exposed to MA-related cue paradigms to induce brain addiction states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues.

Treatment:

Device: Closed-loop tACS stimulation based on addiction-induced states