Back to resultsPaired Associative Stimulation in Methamphetamine Addiction
Primary Purpose
Methamphetamine-dependence
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MagPro X100 device (MagVenture, Farum, Denmark)
Sponsored by
About this trial
This is an interventional basic science trial for Methamphetamine-dependence focused on measuring Paired Associative Stimulation, Frontoparietal Pathway, Transcranial Magnetic Stimulation, Cognitive Function
Eligibility Criteria
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
Sites / Locations
- Haifeng Jiang
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
DLPFC+10 IPL
IPL+10 DLPFC
IPL+4 DPLFC
DLPFC+4 IPL
DLPFC+4 MPFC
MPFC+4 DLPFC
DLPFC+10 MPFC
MPFC+10 DLPFC
Arm Description
Stimulation of dorsolateral prefrontal cortex (DLPFC) 10 ms before inferior parietal lobule (IPL) presumes that the DLPFC to IPL input facilitates insula postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Stimulation of IPL 10 ms before DLPFC presumes that the IPL to DLPFC input inhibits insula postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Stimulation of IPL 4 ms before DLPFC is presumed to be too brief for a corticocortical effect but presumes that the DLPFC input to insula inhibits insula postsynaptic output by weakening the IPL to insula input, thereby impairing cognition response.
Stimulation of DLPFC 4 ms before IPL is presumed to be too brief for a corticocortical effect but presumes that the DLPFC input to insula potentiates insula postsynaptic output by strengthening the IPL to insula input, thereby improving cognition response.
Stimulation of DLPFC 4 ms before medial prefrontal cortex (MPFC) presumes that the DLPFC input facilitates MPFC postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Stimulation of MPFC 4 ms before DLPFC presumes that the DLPFC input inhibits MPFC postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Stimulation of DLPFC 10 ms before medial prefrontal cortex (MPFC) presumes that the DLPFC input facilitates MPFC postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Stimulation of MPFC 10 ms before DLPFC presumes that the DLPFC input inhibits MPFC postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03910608
First Posted
April 5, 2019
Last Updated
September 13, 2021
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03910608
Brief Title
Paired Associative Stimulation in Methamphetamine Addiction
Official Title
The Mechanisms of Cortico-cortical and Cortico-subcortical Networks in Methamphetamine Addiction by Paired Associative Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks to study cognitive deficits in methamphetamine addiction.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine-dependence
Keywords
Paired Associative Stimulation, Frontoparietal Pathway, Transcranial Magnetic Stimulation, Cognitive Function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DLPFC+10 IPL
Arm Type
Experimental
Arm Description
Stimulation of dorsolateral prefrontal cortex (DLPFC) 10 ms before inferior parietal lobule (IPL) presumes that the DLPFC to IPL input facilitates insula postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Arm Title
IPL+10 DLPFC
Arm Type
Experimental
Arm Description
Stimulation of IPL 10 ms before DLPFC presumes that the IPL to DLPFC input inhibits insula postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Arm Title
IPL+4 DPLFC
Arm Type
Experimental
Arm Description
Stimulation of IPL 4 ms before DLPFC is presumed to be too brief for a corticocortical effect but presumes that the DLPFC input to insula inhibits insula postsynaptic output by weakening the IPL to insula input, thereby impairing cognition response.
Arm Title
DLPFC+4 IPL
Arm Type
Experimental
Arm Description
Stimulation of DLPFC 4 ms before IPL is presumed to be too brief for a corticocortical effect but presumes that the DLPFC input to insula potentiates insula postsynaptic output by strengthening the IPL to insula input, thereby improving cognition response.
Arm Title
DLPFC+4 MPFC
Arm Type
Experimental
Arm Description
Stimulation of DLPFC 4 ms before medial prefrontal cortex (MPFC) presumes that the DLPFC input facilitates MPFC postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Arm Title
MPFC+4 DLPFC
Arm Type
Experimental
Arm Description
Stimulation of MPFC 4 ms before DLPFC presumes that the DLPFC input inhibits MPFC postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Arm Title
DLPFC+10 MPFC
Arm Type
Experimental
Arm Description
Stimulation of DLPFC 10 ms before medial prefrontal cortex (MPFC) presumes that the DLPFC input facilitates MPFC postsynaptic output activity, thereby improving cognition response via a long term potentiation-like effect.
Arm Title
MPFC+10 DLPFC
Arm Type
Experimental
Arm Description
Stimulation of MPFC 10 ms before DLPFC presumes that the DLPFC input inhibits MPFC postsynaptic output activity, thereby impairing cognition response via a long term depression-like effect.
Intervention Type
Device
Intervention Name(s)
MagPro X100 device (MagVenture, Farum, Denmark)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of working memory
Description
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.
Time Frame
30 minutes
Title
Change of response inhibition
Description
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.
Time Frame
30 minutes
Title
Change of attention bias
Description
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.
Time Frame
30 minutes
Title
Change of risk decision
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change of eeg oscillatory (Alpha, Beta, Theta and Delta)
Description
EEG was recorded to evaluate the changes in the oscillatory domain before and after the stimulation.
Time Frame
30 minutes
Title
Change of eeg functional connectivity (Alpha, Beta, Theta and Delta)
Description
EEG was recorded to evaluate the changes of functional connectivity before and after the stimulation.
Time Frame
30 minutes
Title
Change of motor evoked potential
Description
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.
Time Frame
30 minutes
Title
Change of resting motor threshold
Description
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.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Jiang, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haifeng Jiang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Paired Associative Stimulation in Methamphetamine Addiction
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