Paired Associative Stimulation in Methamphetamine Addiction

Methamphetamine-dependence Clinical Trial

Official title:

The Mechanisms of Cortico-cortical and Cortico-subcortical Networks in Methamphetamine Addiction by Paired Associative Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03910608
• Other study ID #: HFJiang-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks to study cognitive deficits in methamphetamine addiction.

Description:

Paired associative stimulation (PAS) is a form of transcranial magnetic stimulation in which paired pulses can induce plasticity at cortical synapses, producing long-term potentiation (LTP) or long-term depression (LTD) effect. The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks (frontoparietal control pathway) by using different intervals between the paired pulses to explore the mechanism of cognitive deficits in methamphetamine addiction. The investigators hypothesize that different temporal sequences of cortical stimulation could produce facilitation or inhibition effect.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
• Junior high school degree or above
• Normal vision and hearing
• Dextromanual

Exclusion Criteria:

• Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
• Have cognitive-promoting drugs in the last 6 months
• Other substance abuse or dependence in recent five years (except nicotine)
• Mental impairment, Intelligence Quotient (IQ) < 70
• Mental disorders
• Physical disease

Related Conditions & MeSH terms

• Behavior, Addictive
• Methamphetamine-dependence

Intervention

Device:
• MagPro X100 device (MagVenture, Farum, Denmark)
Each cPAS experimental session contained 100 pairs of stimuli at 0.2 Hz. The experimental conditions differed in the interstimulus interval of the paired pulses. DLPFC stimulation precedes IPL/MPFC stimulation by 10 ms (DLPFC+10) or by 4 ms (DLPFC+4), and IPL/MPFC stimulation precedes DLPFC stimulation by 4 ms (IPL/MPFC+4) or by 10 ms (IPL+10).

Locations

Country	Name	City	State
China	Haifeng Jiang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of working memory	The N-Back is a working memory task where the subject is presented with a sequence of stimuli (letters). The task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence.	30 minutes
Primary	Change of response inhibition	Response inhibition was assessed with the SST (Cambridge Cognition, Cambridge, UK). The subject responded to an arrow (go signal), pointing either right or left, by pressing one of two buttons with the right or left index finger. If an audio tone (stop signal) was present, the subject needed to withhold the response.	30 minutes
Primary	Change of attention bias	During the dot-probe task, participants are situated in front of a computer screen with their chin securely placed on a chin rest. Participants are asked to stare at a fixation cross on the center of the screen. Two stimuli, one of which is neutral and one of which is threatening, appear randomly on either side of the screen. The stimuli are presented for a predetermined length of time (most commonly 500ms), before a dot is presented in the location of one former stimulus. Participants are instructed to indicate the location of this dot as quickly as possible, either via keyboard or response box.	30 minutes
Primary	Change of risk decision	The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. In the task, the participant is presented with a balloon and offered the chance to earn money by pumping the balloon up by clicking a button. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes.	30 minutes
Secondary	Change of eeg oscillatory (Alpha, Beta, Theta and Delta)	EEG was recorded to evaluate the changes in the oscillatory domain before and after the stimulation.	30 minutes
Secondary	Change of eeg functional connectivity (Alpha, Beta, Theta and Delta)	EEG was recorded to evaluate the changes of functional connectivity before and after the stimulation.	30 minutes
Secondary	Change of motor evoked potential	Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The peak-to-peak amplitude of the EMG response will be measured.	30 minutes
Secondary	Change of resting motor threshold	Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The lowest stimulator output needed to elicit a consistent response will be recorded.	30 minutes