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Prospective Cohort Study on the Natural Disease Course Follow-up and Cognitive Training Intervention Effects in PD-SCI and PD-MCI Patients

Prospective Cohort Study on the Natural Disease Course Follow-up and Cognitive Training Intervention Effects in PD-SCI and PD-MCI Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097126
Enrollment
Unknown
Registered
2025-02-13
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Parkinson's disease

Interventions

PD-SCI BBRT intervention group:BBRT online training
PD-SCI control group:Health education
PD-MCI BBRT intervention group:BBRT online training
PD-MCI control group:Health education

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 55-80y; 2. Educational attainment: Primary 6 and above, with physical, cognitive, hearing, speech, literacy and language skills required to participate in all tests and training; 3. Willing and able to provide informed consent in accordance with GCP and local guidelines; 4. Offline patients are required to be able to cooperate with the completion of brain MRI scans; 5. Consistent with the diagnosis of MDS primary PD; Meet the diagnostic criteria of PD-SCI or PD-MCI (all PD patients were diagnosed with cognitive impairment by Bosten SCS cognitive screening, self-assessment of anxiety and depression (SAS=24 points excluded dementia; Among them, SCCQ-PD >=1 and =26 points indicated PD-SCI, and MOCA>=21 points and <26 points indicated PD-MCI. During follow-up, MOCA <21 considered progression to dementia).

Exclusion criteria

Exclusion criteria: 1. Dementia, severe anxiety or depression; 2. History of head trauma or surgery, post-DBS surgery, or individuals who are unable to undergo MRI examination; 3. Exclude cognitive decline caused by other causes (e.g., cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Alzheimer's disease, dementia with Lewy bodies, traumatic brain dementia, epilepsy, other physical and chemical factors (drugs, alcohol, CO, etc.), important medical diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial mass lesions (subdural hematoma, brain tumors), endocrine system lesions (thyroid disease, parathyroid disease), and dementia caused by vitamins or any other cause; 4. Exclusion of drugs that improve cognitive function: including cholinesterase inhibitors, N-methyl-D-aspartate (NMDA) antagonists (memantine), and various Chinese and Western drugs that can improve memory or cognition; 5. Exclusion from participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Change of MOCA (Montreal Cognitive Assessment);Change of MMSE(Mini-Mental State Examination);

Secondary

MeasureTime frame
Difference of conversion rate to dementia;Change of quality of life;Change of emotional state;Change of severity of motor symptoms;Change of MRI Neuroimaging;

Countries

China

Contacts

Public ContactShengdi Chen

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

chensd@rjh.com.cn+86 138 1801 8166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026