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 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT07166432
Eligibility Criteria:
Inclusion Criteria:
* 1\. Clinically and biochemically confirmed ACTH-dependent or ACTH-independent Cushing syndrome (loss of serum cortisol circadian rhythm, elevated 24-hour urinary free cortisol, and failure to suppress on low-dose dexamethasone suppression test).
2\. Cranial MRI demonstrating unequivocal cerebellar atrophy (CCAS imaging criterion: cerebellar hemisphere or vermian volume ≥1.5 SD below age-matched normative data).
3\. Established clinical diagnosis of CCAS (meets Schmahmann criteria, CCAS-S total score ≥20).
4\. Cerebellar ataxia rating scale (SARATA) ≥10, indicating at least moderate motor ataxia.
5\. Positive cognitive impairment screen (MoCA \<26, or Z-scores ≤-1.5 in at least two cognitive domains).
6\. Willingness to undergo minimally invasive epidural cerebellar stimulation and provision of written informed consent.
Exclusion Criteria:
Patients with significant systemic disease; occurrence of major complications or irreproducible, critical deviations in data collection or experimental procedures; or any circumstance rendering continued participation inappropriate-including clinical deterioration, serious adverse events, or poor compliance-will result in discontinuation of the subject's enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07166432
Study Brief:
Protocol Section:
NCT07166432