- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242058
QST-Pupillometry in Sickle Cell Disease Patients (QST)
January 17, 2020 updated by: Julia Finkel
Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20010
- Children's National Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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)
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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)
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Healthy control group
39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.
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Pain Crisis group
30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)
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Pain Service group
10 patients without sickle cell disease admitted to the pain service.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.
Time Frame: change between baseline and at 90day follow-up
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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).
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change between baseline and at 90day follow-up
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Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.
Time Frame: change over 8 consecutive days
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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).
|
change over 8 consecutive days
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Measure mechanical responsiveness in outpatient groups.
Time Frame: change between baseline and 90 day follow-up
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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).
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change between baseline and 90 day follow-up
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Measure mechanical responsiveness in inpatient groups.
Time Frame: change over 8 consecutive days
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Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).
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change over 8 consecutive days
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Measuring the pupil responsiveness in outpatient groups.
Time Frame: change between baseline and 90 day follow-up
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Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).
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change between baseline and 90 day follow-up
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Measuring the pupil responsiveness in inpatient groups.
Time Frame: change over 8 consecutive days
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Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).
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change over 8 consecutive days
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Measuring electrical sensitivity in outpatient groups.
Time Frame: change between baseline and at 90day follow-up
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Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).
|
change between baseline and at 90day follow-up
|
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).
|
change over 8 consecutive days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julia Finkel, MD, Children's National Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
September 13, 2013
First Submitted That Met QC Criteria
September 14, 2014
First Posted (Estimate)
September 16, 2014
Study Record Updates
Last Update Posted (Actual)
January 21, 2020
Last Update Submitted That Met QC Criteria
January 17, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QST-Pupillo3614
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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