Participate in Research Studies

Anxiety Risk in Youth with Cyclic Vomiting Syndrome: Threat Perception, Coping and Physiological Reactivity

If you are between the ages of 13 to 18 and have cyclic vomiting syndrome, we invite you to participate in a study on anxiety risk factors in cyclic vomiting syndrome.

This study is being conducted by Sally Tarbell, Ph.D. at the Children’s Hospital of Colorado, at the Anschutz Medical Campus of the University of Colorado, Aurora, CO.

This study will require two visits to Children’s Hospital of Colorado.

COMIRB Protocol Number: 12-0424, Approved: 4/27/2012.

For more information call Dr. Sally Tarbell 720-777-6255 or Amanda Millar 303-724-7667. Or email  Dr. Sally Tarbell .

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Prospective Registry in Cyclic Vomiting Syndrome at MGH

Description of Study:  The researchers are looking for people to take part in the Cyclic Vomiting Syndrome Prospective Registry Study.  They are exploring the causes, progression, and impact of the disease.

Basic Criteria Eligibility:   Subjects must be diagnosed with CVS by a physician and must be 18 years of age or older

During Study Visits:  Subjects must be present in order to participate in the study. During study visits, we will be:

  • Performing a short physical exam.
  • Asking you questions about your medical and family history.
  • Drawing a blood sample.
  • Asking for a urine sample.
  • Asking for a saliva sample.
  • Asking questions to see if you qualify to take part in this research study.
  • Asking you to fill out questionnaires about your general health, mental health, gastrointestinal health, and quality of life.

Principal Investigator:   Dr. Braden Kuo
Study Coordinator:   Shahar Castel, 617-726-0196

Please call the study coordinator, Shahar Caste, for more information.

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Resting State Brain Response to Chronic Nausea and Cuff Pain

Description of Study:  The purpose of the study is to help us understand what parts of the brain are involved when you are at rest. We would also like to find out what parts of the brain are involved when pain caused by pressure on your leg is given to you while you are at rest.

For this study, we are enrolling both adults with Cyclic Vomiting Syndrome and healthy adults. Patients with Cyclic Vomiting Syndrome tend to suffer from episodes of severe nausea and vomiting. Our goal is to be able to compare how the brain wiring is connected and how the brain responds to feelings of nausea between Cyclic Vomiting Patients and healthy adults. We will look at the brain response at both the resting state and the cuff pain stimulation. In doing this study, we hope to better understand brain wiring in Cyclic Vomiting Syndrome and nausea.

Basic Criteria Eligibility: 

This study will aim to evaluate patients (n=25) diagnosed with CVS who are at least 48 hours following a CVS attack or any nausea/vomiting episode. To be eligible:

  1. Subjects must be between the ages of 18 to 80 years
  2. Diagnosis of Cyclic Vomiting Syndrome by Rome III criteria (The Rome criterion is a system developed to classify the functional gastrointestinal disorders (FGIDs), disorders of the digestive system in which symptoms cannot be explained by the presence of structural or tissue abnormality, based on clinical symptoms).
  3. English Speaking

EXCLUSION:

  1. Subjects who currently have an acute illness,
  2. Subjects who are awaiting transplantation, and
  3. Subjects who have a chronic illness, such as kidney failure, congestive heart failure, and diabetes.
  4. Subjects who have used prescription benzodiazepines within the previous 3 days, used prescription opioids and who have self-reported use of cannabinoids (such as marijuana) within the previous 7 days.
  5. Subjects who have had any nausea/vomiting episode within 48 hours prior to experimental session.
  6. Women cannot be pregnant or plan to become pregnant during the course of the study. Women will be asked about their last menstrual cycle and the method of contraception use.

We also ask that subjects avoid alcohol beverages for at least 24 hours prior to each experimental sessions, and that subjects not drink coffee (or caffeinated beverages) or smoke in the morning before the experimental sessions requiring brain imaging.

During Study Visits:  Subjects must be present in order to participate in the study.

During study visit 1 you will become familiar with our study set-up:

  • You will have an inflatable cuff placed around the calf muscle on your leg. This cuff is attached to a machine that controls the pressure of the air that will inflate the cuff.
  • You will be trained to rate your pain sensation while the cuff is being inflated.
  • We will measure your response to cuff pain. The air pressure in the cuff will be increased for a period of time to cause slight discomfort in order for us to assess the pain level. The pain should go away within several seconds after the cuff is deflated.

We use this session to calibrate the cuff machine for your individual pain tolerance levels. This visit will prepare you to feel comfortable in the MRI machine and also to feel comfortable rating your pain.

During study visit 2:

  • A Magnetic Resonance Imaging (MRI) machine will be used to find out if your brain changes when you are at rest and painful pressure is applied to your leg.
  • Pictures of your brain will be taken while you undergo painful stimulation.
  • You will be asked to rate your pain during this session as you did in the first study visit.

Please note: you will be asked to complete several questionnaires during both study visits.

Principal Investigator:  Dr. Braden Kuo
Study Coordinator:  Shahar Castel, 617-726-0196

Please call the study coordinator, Shahar Caste, for more information.

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Endocannabinoid Concentration in Patients with CVS
2012

The volunteers will have to live within 50 miles of  the Medical College of Wisconsin. Researchers at the Medical College of Wisconsin are seeking individuals with Cyclic Vomiting Syndrome, over the age of 18, to participate in a study on endocannabinoid concentration in patients with CVS. Your participation will help us enhance  patient care in the future. We can also send nurses on home visits to collect samples in an episode if the CVS patient is within a 50 mile radius of the Medical College of Wisconsin.  Eligible volunteers will receive compensation for their participation.

For more information, please contact
Dr. Venkatesan/Megan Campfield
at (414) 955-6836
or Yelena at 414-955-7095

Dr. Thangam Venkatesan in collaboration with the CVSA and Froedtert hospital
was granted the 2013 “Innovations in Health Care Delivery award.” This grant
will be used to implement innovative healthcare delivery systems utilizing
electronic physician-patient portals to enhance patient engagement and
optimize patient-provider health information exchange. We will be designing
an educational CVS “app” and also use REDCap, a Research electronic Data
Capture system to collect health information and track patient outcomes.
This is a unique collaborative effort between the Division of
Gastroenterology and Hepatology, Froedtert hospital, the CTSI and patient
volunteers including the Cyclic Vomiting Syndrome Association (CVSA). The
long-term goal of our work is to establish a comprehensive, collaborative,
and patient-focused program for CVS patients that addresses chronic disease
management and improves outcomes.

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Anxiety Risk in Youth with Cyclic Vomiting Syndrome: Threat Perception, Coping and Physiological Reactivity

If you are between the ages of 13 to 18 and have cyclic vomiting syndrome, we invite you to participate in a study on anxiety risk factors in cyclic vomiting syndrome.

This study is being conducted by Sally Tarbell, Ph.D. at the Children’s Hospital of Colorado, at the Anschutz Medical Campus of the University of Colorado, Aurora, CO.

This study will require two visits to Children’s Hospital of Colorado.

COMIRB Protocol Number: 12-0424, Approved: 4/27/2012.

For more information call Dr. Sally Tarbell 720-777-6255 or Amanda Millar 303-724-7667. Or email  Dr. Sally Tarbell .