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Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome

Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07166432
Enrollment
200
Registered
2025-09-10
Start date
2025-06-28
Completion date
2028-06-01
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Atrophy, Etiology, Physiopathology

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.

Interventions

observational diagnostic model development

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
A dual clinical response at 12 weeks post-treatment, defined as a ≥5-point improvement in the Cerebellar Cognitive Affective Syndrome Scale (CCAS-S) total score AND a ≥6-point improvement in the Scale for Assessment and Rating of Ataxia (SARATA) totalfrom 2025 to 2028

Countries

China

Contacts

Primary ContactZheng Zhang
doczhz@aliyun.com139 0137 1490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026