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NCT Number: NCT07166432

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology, Peking University First Hospital, Beijing, 100034

Beijing, China

Location status: Recruiting

Location contact

Zheng Zhang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • Cranial MRI demonstrating unequivocal cerebellar atrophy (CCAS imaging criterion: cerebellar hemisphere or vermian volume ≥1.5 SD below age-matched normative data).
  • Established clinical diagnosis of CCAS (meets Schmahmann criteria, CCAS-S total score ≥20).
  • Cerebellar ataxia rating scale (SARATA) ≥10, indicating at least moderate motor ataxia.
  • Positive cognitive impairment screen (MoCA <26, or Z-scores ≤-1.5 in at least two cognitive domains).
  • 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.

Treatment and study plan

observational diagnostic model development

Other

observational diagnostic model development

Primary outcomes

  1. 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) total

    Time frame: from 2025 to 2028

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Zhang

CONTACT

[email protected]

139 0137 1490

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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