Minimally invasive bidirectional epidural cerebellar stimulation for cognitive and motor problems from Cushing's-related cerebellar atrophy
Official title: Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
Run by Peking University First Hospital · NCT07166432 · Data updated 2026-11-12
This project tests a minimally invasive epidural cerebellar stimulation system to see if it improves thinking and movement problems in people with cerebellar atrophy and cerebellar cognitive affective syndrome caused by Cushing's syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 28, 2025 |
| Main results expected | June 1, 2028 |
| Study ends | June 1, 2028 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07166432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with biochemically confirmed ACTH-dependent or independent Cushing's syndrome, MRI-proven cerebellar atrophy meeting the CCAS imaging criterion, a clinical CCAS diagnosis with moderate ataxia and cognitive impairment, and willingness to undergo epidural cerebellar stimulation and follow-up.
✕Probably not a fit
Patients without Cushing's-related cerebellar atrophy, those with severe systemic illness or contraindications to epidural procedures, or those who do not meet CCAS diagnostic thresholds are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project uses Cushing's syndrome–related cerebellar atrophy as a model to link neuro‑endocrine immune changes with cognitive and motor deficits. It combines detailed clinical phenotyping, MRI volumetrics, molecular assays of microglial and immune signaling, and application of a novel minimally invasive brain‑machine fusion delivering bidirectional epidural cerebellar stimulation. The design emphasizes mechanistic discovery and diagnostic model development rather than a randomized therapeutic trial, with serial clinical, cognitive, imaging, and biomarker endpoints. Findings aim to clarify how glucocorticoid‑driven immune changes affect cerebellar circuits and how targeted neuromodulation may modify those pathways.
Why it matters
Potential benefit: If successful, the approach could reduce cerebellar ataxia and cognitive symptoms and point to a new neuromodulation treatment pathway for CCAS.
How similar studies have gone: Related neuromodulation work, including noninvasive cerebellar stimulation and limited invasive approaches, has shown promising effects on motor and cognitive outcomes in small studies, but this specific minimally invasive bidirectional epidural technique is novel and largely untested clinically.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Department of Urology, Peking University First Hospital, Beijing, 100034
Beijing, China Recruiting
Study contacts
- Study coordinator: Zheng Zhang
- Email: doczhz@aliyun.com
- Phone: 139 0137 1490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.