Individualized Neuromodulation 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

NCT06165198

MZhao-013

Details and patient eligibility

About

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop tACS based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tACS methods.

Full description

The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive transcranial alternating current stimulation (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: 9 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 or capable of effectively cooperating in questionnaire and behavioral task evaluations.
• Meet the diagnostic criteria set forth by the DSM-5 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: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Closed-loop tACS stimulation based on addiction-induced states

Experimental group

Description:

Participants will receive closed-loop tACS interventions at different frequencies, with a 5-day interval between sessions. During each session, participants will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be triggered only when specific EEG signals associated with MA cues are identified. The optimal frequency will be determined at the group level based on prespecified cue-reactivity EEG and inhibitory-control outcomes. Subsequently, participants will receive two additional control conditions at the identified optimal frequency: random-time stimulation, which will deliver the same number of stimulation events at pseudorandom time points independently of the EEG-defined brain state, and open-loop continuous stimulation, which will deliver an equivalent total stimulation dose continuously.

Treatment:

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