Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2022-05-16
2027-06-30
Brief Summary
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Detailed Description
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Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).
Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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CVS subjects
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
TMS Paired-Pulse assessment of cortical excitability
Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).
Autonomic activity
Autonomic function will be determined using continuously recorded EKG and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.
healthy, non-CVS subjects
Subjects not diagnosed with CVS
TMS Paired-Pulse assessment of cortical excitability
Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).
Autonomic activity
Autonomic function will be determined using continuously recorded EKG and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.
Interventions
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TMS Paired-Pulse assessment of cortical excitability
Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).
Autonomic activity
Autonomic function will be determined using continuously recorded EKG and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* psychosis or altered cognitive status
* history of head injury, metal in the skull, stroke, or a history of seizures or a history of syncope (fainting or passing out)
* implantable devices, such as a pacemaker or nerve stimulator
* current use of the following medications or use of substances which are known to lower the seizure threshold: clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
* pregnancy
18 Years
60 Years
ALL
Yes
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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David Levinthal
Assistant Professor
Principal Investigators
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David J Levinthal, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY21120001
Identifier Type: -
Identifier Source: org_study_id
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