Health TrialsbyHealthPanel

Closed-loop TMS for the Core Clinical Features of the Methamphetamine Use Disorder

ConditionsMethamphetamine Use DisorderSubstance Use DisorderCue-reactivityCraving
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Mental Health Center

About this trial

The goal of this clinical trial is to evaluate whether closed-loop transcranial magnetic stimulation (TMS) can improve core clinical symptoms in individuals with methamphetamine use disorder (MUD), such as cue-reactivity and impaired inhibitory control.

The main questions it aims to answer are:

Can closed-loop TMS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and cue-reactivity task, compared to a conventional treatment protocol and random TMS ? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST), more effectively than the other stimulation modes? Researchers will compare closed-loop, conventional, and random TMS conditions to determine whether closed-loop yields superior symptom improvement.

Participants will:

Be randomly assigned to one of the three stimulation group (closed-loop, conventional and random) according to a pre generated random number table, and receive the corresponding stimulation session.

Undergo cue-reactivity assessment using VAS and cue-reactivity task, and complete the SST before and after each stimulation session.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Closed-loop TMS

    Device

    Participants receive theta burst stimulation (TBS), triggered by real-time EEG signals recorded during a cue-reactivity task. This closed-loop protocol aims to deliver stimulation precisely during neural states associated with cue-induced craving.

  • Conventional TMS

    Device

    Participants receive TBS, delivered at a standard iTBS protocol (3-pulse 50-Hz bursts given at every 200 ms (i.e. at 5 Hz), 2s on and 8s off, with 1200 pulses in total), without EEG or task engagement.

  • Random TMS

    Device

    Participants receive TBS, triggered by a random sequence unrelated to real-time EEG features.

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: Closed-loop GroupExperimental treatment 1 intervention
Group B: Conventional TMS GroupActive comparator 1 intervention
Group C: Sham GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cue-Induced Neural Reactivity During Before and After Stimulation

EEG signals will be recorded while participants perform a cue-reactivity task during both the training phase (no stimulation) and the stimulation phase (with TMS). The primary outcome will be changes in cue-induced neural reactivity, defined by EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power) in response to methamphetamine-related cues. Comparisons will be made across stimulation conditions (closed-loop, conventional, random) and phases (pre- vs. during stimulation).

Time frame
During cue-reactivity task in training and stimulation phases of each session.

Secondary outcomes

1

Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)

Participants will rate their craving levels after viewing methamphetamine-related videos using a Visual Analog Scale (VAS), ranging from 0 (no craving) to 100 (maximum craving). Craving scores will be recorded immediately before and after each stimulation session under all three stimulation conditions.

Time frame
Before and within 30 minutes after stimulation
2

Change in Inhibitory Control Assessed by Stop Signal Task (SST)

Participants will complete the Stop Signal Task (SST) before and after each stimulation session. Measures such as Stop Signal Reaction Time (SSRT) and accuracy will be used to assess changes in inhibitory control performance across different stimulation conditions.

Time frame
Before and within 30 minutes after stimulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Mental Health Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: