QST-Pupillometry in Sickle Cell Disease Patients

NCT02242058 | Completed DMC

• 1 other identifier: QST-Pupillo3614
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

Study Arms (5)

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

Interventions

Quantitative sensory testing OTHER

Healthy control group; High frequency pain group; Low Pain Frequency group; Pain Crisis group; Pain Service group

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julia Finkel: lead

Study Sites (2)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood samples at baseline to be stored in the Pain Neurobiology laboratory for future biochemical studies.

Study Officials

• Julia Finkel, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 16, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

US (2)