QST-Pupillometry in Sickle Cell Disease Patients

NCT ID: NCT02242058

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Quantitative sensory testing

Intervention Type OTHER

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)

Quantitative sensory testing

Intervention Type OTHER

Healthy control group

39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.

Quantitative sensory testing

Intervention Type OTHER

Pain Crisis group

30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)

Quantitative sensory testing

Intervention Type OTHER

Pain Service group

10 patients without sickle cell disease admitted to the pain service.

Quantitative sensory testing

Intervention Type OTHER

Interventions

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Quantitative sensory testing

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Julia Finkel

OTHER

Sponsor Role lead

Responsible Party

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Julia Finkel

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Julia Finkel, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Health System

Washington D.C., District of Columbia, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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QST-Pupillo3614

Identifier Type: -

Identifier Source: org_study_id

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