Clinical trial NCT02242058: QST-Pupillometry in Sickle Cell Disease Patients
Official title: Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 96
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.

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.


Eligibility 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.

Primary outcomes:
measure: Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.
timeFrame: change between baseline and at 90day follow-up
measure: Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.
timeFrame: change over 8 consecutive days
measure: Measure mechanical responsiveness in outpatient groups.
timeFrame: change between baseline and 90 day follow-up
measure: Measure mechanical responsiveness in inpatient groups.
timeFrame: change over 8 consecutive days
measure: Measuring the pupil responsiveness in outpatient groups.
timeFrame: change between baseline and 90 day follow-up
measure: Measuring the pupil responsiveness in inpatient groups.
timeFrame: change over 8 consecutive days
measure: Measuring electrical sensitivity in outpatient groups.
timeFrame: change between baseline and at 90day follow-up
measure: Measuring electrical sensitivity in inpatient groups.
timeFrame: change over 8 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Health System
name: Julia Finkel, MD
role: PRINCIPAL_INVESTIGATOR
References: