Cortical Excitability in Cyclic Vomiting Syndrome
Primary Purpose
Cyclic Vomiting Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS Paired-Pulse assessment of cortical excitability
Autonomic activity
Sponsored by
About this trial
This is an interventional basic science trial for Cyclic Vomiting Syndrome
Eligibility Criteria
Inclusion Criteria:
- diagnosis of CVS
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CVS subjects
healthy, non-CVS subjects
Arm Description
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
Subjects not diagnosed with CVS
Outcomes
Primary Outcome Measures
Paired-pulse ratios
Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
Secondary Outcome Measures
TMS motor threshold
TMS stimulator output necessary to elicit 200 microvolt MEP responses
Cortical silent period
Length (milliseconds) of EMG inactivity following TMS stimulation
Heart rate variability
Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals
Full Information
NCT ID
NCT05256160
First Posted
February 15, 2022
Last Updated
April 7, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT05256160
Brief Title
Cortical Excitability in Cyclic Vomiting Syndrome
Official Title
Cortical Excitability in Cyclic Vomiting Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Vomiting Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CVS subjects
Arm Type
Experimental
Arm Description
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
Arm Title
healthy, non-CVS subjects
Arm Type
Active Comparator
Arm Description
Subjects not diagnosed with CVS
Intervention Type
Other
Intervention Name(s)
TMS Paired-Pulse assessment of cortical excitability
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Autonomic activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Paired-pulse ratios
Description
Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
Time Frame
Multiple study sessions spanning up to 12 months
Secondary Outcome Measure Information:
Title
TMS motor threshold
Description
TMS stimulator output necessary to elicit 200 microvolt MEP responses
Time Frame
Multiple study sessions spanning up to 12 months
Title
Cortical silent period
Description
Length (milliseconds) of EMG inactivity following TMS stimulation
Time Frame
Multiple study sessions spanning up to 12 months
Title
Heart rate variability
Description
Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals
Time Frame
Multiple study sessions spanning up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of CVS
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul HM Kullmann, PhD
Phone
412-647-1533
Email
phmk@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David J Levinthal, MD PhD
Phone
412-303-0525
Email
levinthald@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Levinthal, MD PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Cortical Excitability in Cyclic Vomiting Syndrome
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