- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910608
Paired Associative Stimulation in Methamphetamine Addiction
September 13, 2021 updated by: Haifeng Jiang, Shanghai Mental Health Center
The Mechanisms of Cortico-cortical and Cortico-subcortical Networks in Methamphetamine Addiction by Paired Associative Stimulation
The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks to study cognitive deficits in methamphetamine addiction.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Haifeng Jiang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DLPFC+10 IPL
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.
|
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).
|
Experimental: IPL+10 DLPFC
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.
|
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).
|
Experimental: IPL+4 DPLFC
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.
|
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).
|
Experimental: DLPFC+4 IPL
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.
|
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).
|
Experimental: DLPFC+4 MPFC
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.
|
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).
|
Experimental: MPFC+4 DLPFC
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.
|
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).
|
Experimental: DLPFC+10 MPFC
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.
|
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).
|
Experimental: MPFC+10 DLPFC
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of working memory
Time Frame: 30 minutes
|
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
|
Change of response inhibition
Time Frame: 30 minutes
|
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
|
Change of attention bias
Time Frame: 30 minutes
|
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
|
Change of risk decision
Time Frame: 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of eeg oscillatory (Alpha, Beta, Theta and Delta)
Time Frame: 30 minutes
|
EEG was recorded to evaluate the changes in the oscillatory domain before and after the stimulation.
|
30 minutes
|
Change of eeg functional connectivity (Alpha, Beta, Theta and Delta)
Time Frame: 30 minutes
|
EEG was recorded to evaluate the changes of functional connectivity before and after the stimulation.
|
30 minutes
|
Change of motor evoked potential
Time Frame: 30 minutes
|
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
|
Change of resting motor threshold
Time Frame: 30 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haifeng Jiang, PhD, Shanghai Mental Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
March 31, 2021
Study Completion (Anticipated)
March 31, 2022
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HFJiang-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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