Cerebellar AtrophyNCT07166432
Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
An observational study of Cerebellar Atrophy and Etiology, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebellar Atrophy, Etiology, Physiopathology
- What is being tested?
- observational diagnostic model development
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2025to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-80 years who have documented hypercortisolism (Cushing syndrome) on clinical testing and are assessed as having decision-making capacity.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Peking University First Hospital, Beijing, 100034
Beijing
Zheng Zhang, doczhz@aliyun.com
About this study
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.
- Conditions
- Cerebellar Atrophy, Etiology, Physiopathology
- Being tested
- observational diagnostic model development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational diagnostic model developmentOther
observational diagnostic model development
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 2025 to 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start28 Jun 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtrophyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166432
- Sponsor's protocol ID
- PKUFH-URO-CCAS-2025-MI-BES
- Status last verified
- Jun 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
- ClinicalTrials.gov ID
- NCT07166432
- Acronym / sponsor ID
- PKUFH-URO-CCAS-2025-MI-BES
- Conditions
- Cerebellar Atrophy, Etiology, Physiopathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 years who have documented hypercortisolism (Cushing syndrome) on clinical testing and are assessed as having decision-making capacity.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational diagnostic model developmentobservational diagnostic model development | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellar Atrophy and Etiology, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Zhang (139 0137 1490, doczhz@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.