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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03910608
Other study ID # HFJiang-003
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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