NCT03910608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

April 5, 2019

Last Update Submit

September 13, 2021

Conditions

Keywords

Paired Associative StimulationFrontoparietal PathwayTranscranial Magnetic StimulationCognitive Function

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Change of eeg oscillatory (Alpha, Beta, Theta and Delta)

    30 minutes

  • Change of eeg functional connectivity (Alpha, Beta, Theta and Delta)

    30 minutes

  • Change of motor evoked potential

    30 minutes

  • Change of resting motor threshold

    30 minutes

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Device: MagPro X100 device (MagVenture, Farum, Denmark)

Interventions

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).

DLPFC+10 IPLDLPFC+10 MPFCDLPFC+4 IPLDLPFC+4 MPFCIPL+10 DLPFCIPL+4 DPLFCMPFC+10 DLPFCMPFC+4 DLPFC

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifeng Jiang

Shanghai, Shanghai Municipality, 200000, China

Location

Study Officials

  • Haifeng Jiang, PhD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 10, 2019

Study Start

May 1, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2022

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations