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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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).
change between baseline and at 90day follow-up
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).
change over 8 consecutive days
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).
change between baseline and 90 day follow-up
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).
change over 8 consecutive days
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).
change between baseline and 90 day follow-up
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).
change over 8 consecutive days
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).
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Julia Finkel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings