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Completed

NCT Number: NCT06165198

Individualized Neuromodulation for the Core Clinical Features of Drug Addiction

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Closed-loop tACS stimulation based on addiction-induced states

Device

We conducted a longitudinal controlled study of closed-loop tACS interventions among MA dependents.This involved implementing interventions based on addiction-induced states through closed-loop tACS stimulation, randomized time-point stimulation, and traditional continuous stimulation.

Primary outcomes

  1. Stop-signal task

    Time frame: through study completion, an average of 1 month

    The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time, Stop-signal delays, Go-task reaction time, and Success and failure inhibition rates.

Secondary outcomes

  1. Changes of electroencephalogram power spectrum

    Time frame: through study completion, an average of 1 month

    Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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