Methamphetamine-dependenceNCT03910608
Paired Associative Stimulation in Methamphetamine Addiction
A study testing MagPro X100 device (MagVenture, Farum, Denmark) in people with Methamphetamine-dependence, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine-dependence
- What is being tested?
- MagPro X100 device (MagVenture, Farum, Denmark)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Methamphetamine-dependence
- Being tested
- MagPro X100 device (MagVenture, Farum, Denmark)
- Keywords
- Paired Associative Stimulation, Frontoparietal Pathway, Transcranial Magnetic Stimulation, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro X100 device (MagVenture, Farum, Denmark)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| DLPFC+10 IPL | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| IPL+10 DLPFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| IPL+4 DPLFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| DLPFC+4 IPL | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| DLPFC+4 MPFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| MPFC+4 DLPFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| DLPFC+10 MPFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
| MPFC+10 DLPFC | Experimental | 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. Receives: Device: MagPro X100 device (MagVenture, Farum, Denmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Secondary outcomes (4)
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-dependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haifeng Jiang, Shanghai Mental Health Center
- Investigators
- Haifeng Jiang, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910608
- Sponsor's protocol ID
- HFJiang-003
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms of Cortico-cortical and Cortico-subcortical Networks in Methamphetamine Addiction by Paired Associative Stimulation
- ClinicalTrials.gov ID
- NCT03910608
- Acronym / sponsor ID
- HFJiang-003
- Conditions
- Methamphetamine-dependence
- Keywords
- Paired Associative Stimulation, Frontoparietal Pathway, Transcranial Magnetic Stimulation, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| DLPFC+10 IPL | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| IPL+10 DLPFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| IPL+4 DPLFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| DLPFC+4 IPL | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| DLPFC+4 MPFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| MPFC+4 DLPFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| DLPFC+10 MPFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
| MPFC+10 DLPFC | Experimental | Device: MagPro X100 device (MagVenture, Farum, Denmark)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | DLPFC+10 IPL, DLPFC+10 MPFC, DLPFC+4 IPL, DLPFC+4 MPFC, IPL+10 DLPFC, IPL+4 DPLFC, MPFC+10 DLPFC, MPFC+4 DLPFC |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Change of eeg oscillatory (Alpha, Beta, Theta and Delta)
Time frame: 30 minutes
Change of eeg functional connectivity (Alpha, Beta, Theta and Delta)
Time frame: 30 minutes
Change of motor evoked potential
Time frame: 30 minutes
Change of resting motor threshold
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haifeng Jiang, PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro X100 device (MagVenture, Farum, Denmark) in people with Methamphetamine-dependence, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of working memory (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.