NCT07166432 Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
| NCT ID | NCT07166432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Cerebellar Atrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-28 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-06-28 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Building on previous findings regarding microglial immune function and the immunosuppressive effects of glucocorticoids, this project centers on the cerebellum's role in cognitive science. Using Cushing's syndrome-induced cerebellar atrophy leading to CCAS as a model, we aim to elucidate the pathogenic mechanisms governed by the neuro-adrenal-immune network and to uncover the molecular basis by which a novel minimally invasive brain-machine fusion system ameliorates cerebellar ataxia and cognitive impairment.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07166432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Cerebellar Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07166432 currently recruiting?
Yes, NCT07166432 is actively recruiting participants. Contact the research team at doczhz@aliyun.com for enrollment information.
Where is the NCT07166432 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07166432 clinical trial?
NCT07166432 is sponsored by Peking University First Hospital. The trial plans to enroll 200 participants.