QST-Pupillometry in Sickle Cell Disease Patients

SCD With Severe Phenotype (HbSS, HbSß0 Thalassemia, HbSOARab) Clinical Trial

— QST  

Official title:

Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242058
• Other study ID #: QST-Pupillo3614
• Status: Completed
• Start date: August 2013
• Est. completion date: November 2018

Study information

• Verified date: January 2020
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• SCD With Severe Phenotype (HbSS, HbSß0 Thalassemia, HbSOARab)
• Thalassemia

Intervention

Other:
• Quantitative sensory testing

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Julia Finkel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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