Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT04854850
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent
2. Men or women aged 18 years and older
3. Diagnosis of Systemic sclerosis, as defined by 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
4. Baseline T score of 45 on the PROMIS-Fatigue scale.
5. Steady daily doses and any immunosuppressive medication, vasodilators, antidepressants and anxiolytic use for 4 weeks prior to baseline.
6. Currently owns and operates an iOS or Android smart phone regularly
7. Ability to comply with the clinical visits schedule and the study-related procedures.
8. Subjects who have struggled with symptoms of SSc (specifically fatigue and Raynauds) who have not received adequate symptom relief from prior treatment attempts (treatment-resistant) will be prioritized.
Exclusion Criteria:
1. Medical and surgical history
* Major surgery within 8 weeks prior to screening
* Participants with an active malignancy.
* End-stage renal disease with an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 (MDRD formula) or on dialysis at the screening visit
* Hepatic insufficiency as defined by the Child-Pugh criteria
* Hospitalization for any reason within four weeks of the study baseline visit.
* History of sympathectomy or stellate ganglion block
* Significant interstitial lung disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
* Pulmonary hypertension with change in medications in the preceding four weeks
* Actively prescribed standing doses of beta-blockers.
* Actively prescribed standing doses of sedatives, hypnotics, opioids, or benzodiazepines.
* Active or unstable psychotic disorder requiring current prescriptions of standing doses of antipsychotic medications
* Active suicidal/homicidal ideation or a suicide or homicide attempt in the past year.
2. Pregnant or breastfeeding women
3. Other • Any other condition or therapy that would make the participant unsuitable for this study and will not allow participation for the full planned study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04854850
Study Brief:
Protocol Section:
NCT04854850