We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

QST-Pupillometry in Sickle Cell Disease Patients (QST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02242058
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Zenaide Quezado, Children's Research Institute

Brief Summary:
There has been little progress for effective treatment of pain in sickle cell disease (SCD) patients. Many organizations have recognized that understanding the causes and reducing the burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As patients with SCD face the challenge of living with both acute and chronic pain which is often improperly treated, our translational and interdisciplinary project aims to identify objective measures of pain sensitivity and its biochemical and genetic correlates. We hypothesize that SCD patients will have decreased tolerance to thermal and electrical stimuli.

Condition or disease Intervention/treatment Phase
SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab) Other: Quantitative sensory testing Early Phase 1

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
High frequency pain group
39 pediatric or adult patients with high pain frequency (greater than or equal to 3 ER visits and/or hospitalizations for pain per year over the last two years)
Other: Quantitative sensory testing
Low Pain Frequency group
39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years)
Other: Quantitative sensory testing
Healthy control group
39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.
Other: Quantitative sensory testing
Pain Crisis group
30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)
Other: Quantitative sensory testing
Pain Service group
10 patients without sickle cell disease admitted to the pain service.
Other: Quantitative sensory testing



Primary Outcome Measures :
  1. Measuring thermal responsiveness (perception and tolerance) in the outpatient groups. [ Time Frame: change between baseline and at 90day follow-up ]
    Using a TSA (thermal sensory analyzer), the patients hot and cold perception and tolerance will be measured in the outpatient groups (high-pain and low-pain frequency and controls).

  2. Measuring thermal responsiveness (perception and tolerance) in the inpatient groups. [ Time Frame: change over 8 consecutive days ]
    Using a TSA thermal sensory analyzer, the patients hot and cold perception and tolerance will be measured in the inpatient groups (pain crisis and pain service).

  3. Measure mechanical responsiveness in outpatient groups. [ Time Frame: change between baseline and 90 day follow-up ]
    Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the outpatient groups (high-pain and low-pain frequency and controls).

  4. Measure mechanical responsiveness in inpatient groups. [ Time Frame: change over 8 consecutive days ]
    Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).

  5. Measuring the pupil responsiveness in outpatient groups. [ Time Frame: change between baseline and 90 day follow-up ]
    Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).

  6. Measuring the pupil responsiveness in inpatient groups. [ Time Frame: change over 8 consecutive days ]
    Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).

  7. Measuring electrical sensitivity in outpatient groups. [ Time Frame: change between baseline and at 90day follow-up ]
    Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).

  8. Measuring electrical sensitivity in inpatient groups. [ Time Frame: change over 8 consecutive days ]
    Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (pain service and pain crisis).


Biospecimen Retention:   Samples With DNA
Collection of blood samples at baseline to be stored in the Pain Neurobiology laboratory for future biochemical studies.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.
Criteria

Inclusion Criteria:

  • SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)
  • Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls

Exclusion Criteria:

  • Completed overt clinical stroke or transient ischemic attack;
  • Known severe vasculopathy or Moyamoya disease on brain MRA (Magnetic Resonance Angiography).
  • history of having consumed alcohol within the last 12 hours prior to testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242058


Contacts
Contact: Zena Quezado, MD 202-476-2578 ZQuezado@childrensnational.org

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Zena Quezado, MD         
Sponsors and Collaborators
Children's Research Institute

Responsible Party: Zenaide Quezado, Director, Pain Neurobiology Laboratory, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02242058     History of Changes
Other Study ID Numbers: QST-Pupillo3614
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn