Recruiting

MUSE Intervention

Sponsor:

Mayo Clinic

Code:

NCT04543253

Conditions

Cushing Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MUSE biofeedback

Study Details

Brief summary:

Cushing syndrome (CS) is an endocrine disorder caused by chronic exposure to glucocorticoid (GC) excess. Endogenous CS has an estimated incidence of 0.2 to 5.0 cases per million per year and prevalence of 39 to 79 cases per million in various populations. CS usually affects young women, with a median age at diagnosis of 41.4 with a female-to-male ratio of 3:1. Following a curative surgery for CS, patients develop adrenal insufficiency and require GC replacement postoperatively until the hypothalamic-pituitary-adrenal (HPA) axis recovery occurs. Factors, such as age, gender, BMI, subtypes of CS, duration of symptoms, clinical and biochemical severity and postoperative GC dose have been reported to affect the HPA recovery in small retrospective studies. Glucocorticoid withdrawal syndrome (GWS) is a withdrawal reaction due to decrease in supraphysiological GC concentrations, which occurs after a successful surgery of CS. Glucocorticoid withdrawal syndrome (GWS) is under-recognized entity in patients undergoing curative surgery for endogenous Cushing syndrome.

In this study we aim to determine pre- and post-surgical predictors of the duration and severity of glucocorticoid withdrawal in patients undergoing a curative surgery for cortisol excess and assess the effect of MUSE intervention on GWS severity in patients undergoing curative surgery for CS as compared to standard of care.

Conditions

Cushing Syndrome

Study ID

NCT04543253

Start date

Jul 25, 2019

Status verified date

Aug, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 18 and above,
2. new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS,
3. planning for a curative surgery
4. ability to provide informed consent.

Exclusion Criteria:

1. systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks,
2. inability to provide informed consent

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Arms

Standard of care CS

Patients undergoing curative surgery for any type of CS who will be followed through standard of care after surgery

MUSE intervention CS

Patients undergoing curative surgery for any type of CS who will be introduced to and provided MUSE for use after surgery

Interventions

MUSE biofeedback

biofeedback through a headband

Primary outcome measure

  • Quality of life (SF36) [ Time Frame: periodic 0-24 months ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Irina Bancos, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 3, 2025

Last verified

Aug, 2025

Keywords

  • Hypercortisolism
  • Cushing syndrome
  • Cushing disease
  • Pituitary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-03.