Phase
Condition
Circulation Disorders
Lupus
Pain (Pediatric)
Treatment
Apollo Neuro Device
Sham device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Ability to provide written informed consent,
Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with apositive ANA
Baseline score ≥55 on the FACIT-Fatigue scale,
Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
Steady daily doses and any immunosuppressive medication, vasodilators or othermedications used to treat pulmonary hypertension, antidepressants and anxiolytic usefor 4 weeks prior to baseline
Currently owns and operates an iOS or Android smart phone regularly
Ability to comply with the clinical visits schedule and the study-relatedprocedures.
Exclusion
Exclusion Criteria:
History of sympathectomy or stellate ganglion block
History of Botox injections to the digits within the last 3 months
Diabetes mellitus
Major surgery within 8 weeks
Hospitalization for any reason within four weeks of the study baseline visit
Active malignancy
Pregnant or breastfeeding women,
End-stage renal disease (estimated glomerular filtration rate < 15 mL/min/1.73m2) oron dialysis,
Hepatic insufficiency as defined by function worse than Child-Pugh Class B
Medication exclusions:
actively prescribed standing doses of beta-blockers,
actively prescribed standing doses of sedatives, hypnotics, opioids,benzodiazepines or anti-psychotic medications.
Study Design
Study Description
Connect with a study center
DelRicht Research Center
New Orleans 4335045, Louisiana 4331987 70115
United StatesActive - Recruiting
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
UPMC Arthritis and Autoimmunity Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
University of Pittsburgh and UPMC Scleroderma Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting

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