Cyclic Vomiting SyndromeNCT05256160
Cortical Excitability in Cyclic Vomiting Syndrome
A study testing TMS Paired-Pulse assessment of cortical excitability and Autonomic activity in people with Cyclic Vomiting Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial summary
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cyclic Vomiting Syndrome
- What is being tested?
- TMS Paired-Pulse assessment of cortical excitability and Autonomic activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of CVS
Who cannot join
- history of CVS (for healthy control population only)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
Read the detailed description
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
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
- Cyclic Vomiting Syndrome
- Being tested
- TMS Paired-Pulse assessment of cortical excitability, Autonomic activity
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS Paired-Pulse assessment of cortical excitabilityOther
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 activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CVS subjects | Experimental | Subjects diagnosed with Cyclic Vomiting Syndrome (CVS) Receives: Other: TMS Paired-Pulse assessment of cortical excitability; Other: Autonomic activity |
| healthy, non-CVS subjects | Active comparator | Subjects not diagnosed with CVS Receives: Other: TMS Paired-Pulse assessment of cortical excitability; Other: Autonomic activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired-pulse ratios
Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
Measured: Multiple study sessions spanning up to 12 months
Secondary outcomes (3)
TMS motor threshold
TMS stimulator output necessary to elicit 200 microvolt MEP responses
Measured: Multiple study sessions spanning up to 12 months
Cortical silent period
Length (milliseconds) of EMG inactivity following TMS stimulation
Measured: Multiple study sessions spanning up to 12 months
Heart rate variability
Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals
Measured: Multiple study sessions spanning up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start16 May 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a comparative study looking at differences in electrophysiologic measures of cortical excitability between those with Cyclic Vomiting Syndrome and healthy controls.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Levinthal, University of Pittsburgh
- Investigators
- David J Levinthal, MD PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256160
- Sponsor's protocol ID
- STUDY21120001
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to place participant data into a open-access, shared data repository. However, a data sharing agreement can be made if requested.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability in Cyclic Vomiting Syndrome
- ClinicalTrials.gov ID
- NCT05256160
- Acronym / sponsor ID
- STUDY21120001
- Conditions
- Cyclic Vomiting Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Feb 2022 (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.
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
Detailed description
This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a comparative study looking at differences in electrophysiologic measures of cortical excitability between those with Cyclic Vomiting Syndrome and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| CVS subjects | Experimental | Other: TMS Paired-Pulse assessment of cortical excitability, Other: Autonomic activitySubjects diagnosed with Cyclic Vomiting Syndrome (CVS) |
| healthy, non-CVS subjects | Active comparator | Other: TMS Paired-Pulse assessment of cortical excitability, Other: Autonomic activitySubjects not diagnosed with CVS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosis of CVS
Key exclusion criteria (6 listed)
- history of CVS (for healthy control population only)
- 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
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 |
|---|---|---|
| TMS Paired-Pulse assessment of cortical excitabilityUsing 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). | Other | CVS subjects, healthy, non-CVS subjects |
| Autonomic activityAutonomic 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. | Other | CVS subjects, healthy, non-CVS subjects |
Primary outcome
Paired-pulse ratios
Time frame: Multiple study sessions spanning up to 12 months
Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
3 secondary outcomes
TMS motor threshold
Time frame: Multiple study sessions spanning up to 12 months
Cortical silent period
Time frame: Multiple study sessions spanning up to 12 months
Heart rate variability
Time frame: Multiple study sessions spanning up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. There is no current plan to place participant data into a open-access, shared data repository. However, a data sharing agreement can be made if requested.
Related trials for Cyclic Vomiting Syndrome
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Recruiting
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
Autonomic Reactivity and Personalized Neurostimulation
Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome
RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
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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.
David J Levinthal, MD PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS Paired-Pulse assessment of cortical excitability and Autonomic activity in people with Cyclic Vomiting Syndrome, run by University of Pittsburgh at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elijah D Wright (412-647-1228, edw87@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired-pulse ratios (time frame: Multiple study sessions spanning up to 12 months). 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 Aug 2026.