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Establishment of multimodal diagnostic evaluation system and multicenter cohort study of rehabilitation therapy system for Parkinson's disease

Establishment of multimodal diagnostic evaluation system and multicenter cohort study of rehabilitation therapy system for Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062596
Enrollment
Unknown
Registered
2022-08-13
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Parkinson's disease

Interventions

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All PD patients fulfilled the diagnostic criteria of MDS in 2015; 2. Patients with primary Parkinson's disease aged 55 -75; 3. Hoehn and Yahr stages 1-2.5 were enrolled in this study; 4. Informed consent was obtained from all participants; 5. MMSE >= 24

Exclusion criteria

Exclusion criteria: 1. Parkinson's syndrome and Parkinson's syndrome are caused by drugs, poisoning, metabolic diseases, intracranial infection, genetics, trauma, tumor, autoimmune diseases, cerebrovascular diseases, and other reasons; 2. Patients' compliance is affected due to cognitive dysfunction and informed consent cannot be signed. (Note: In suspicious cases, informed consent should be provided only when a physician not involved in the study confirms that the patient is not dementia, excluding patients with MMSE <= 24). 3. Patients with a history of mental illness; 4. Had a history of active epilepsy (i.e., seizures) within two years prior to enrollment; Patients with degree II or III ATrioventricular block or pathological sinus syndrome; 6. The patient's resting heart rate is lower than 50 beats/min; Patients with congestive heart failure are classified as class III or IV according to the New York Heart Association cardiac function classification; 8. Patients with myocardial infarction within 6 months before enrollment. 9. Other heart diseases (e.g., coronary artery disease) that are clinically significant and may interfere with the completion of the trial; 10. Clinically significant kidney disease that may prevent the patient from completing the test, and/or serum creatinine above the laboratory normal range, and/or blood urea nitrogen above 1.5 times the normal range; 11. Clinically significant liver disease, which may prevent patients from completing the test, and/or total bilirubin, glutamic-oxalacetic transaminase, or glutamic-pyruvic transaminase higher than the normal value in the laboratory, that is, more than 1.2 times the normal value, but still higher than the normal value after review. 12. Patients who are suffering from cancer, or have a history of cancer or a family history of cancer; 13. Patients had a history of surgical procedures in the 180 days prior to enrollment, which the investigator suggested might influence participants in the clinical trial and patients with a history of stereotactic brain surgery; 14. Systolic blood pressure decreased by 20mmHg 5 minutes after being upright compared to the previous measurement of systolic blood pressure after 5 minutes of quiet rest in a recumbent position, and blood pressure decreased with symptoms (i.e., symptomatic postural hypotension); 15. Women of childbearing age who are not taking oral contraceptives/using medically approved contraceptives (Note: all women of childbearing age are required to have a pregnancy test before inclusion); 16. The patient is participating in another clinical trial or was enrolled in another study within the 90 days prior to enrollment. In addition, patients who were randomly enrolled in the study and then dropped out may not be re-enrolled; 17. Skin of the scalp and information collection area has ulceration; 18. Metal implants that affect MRI examination.

Design outcomes

Primary

MeasureTime frame
UPDRS(United Parkinson’s Disease Rating Scale);

Secondary

MeasureTime frame
NFL-Neurofilament light;a-synuclein;Amyloid-ß 40, Amyloid-ß 42;electroencephalograph;Head magnetic resonance imaging;MMSE-Mini-mental State Examination;MoCA-Montreal Cognitive Assessment Test;PDSS-2( Parkinson's disease sleep scale-2);NMSS(non-motor symptoms scale);HAMD(Hamilton Depression Rating Scale);microtubule-associated protein tau;

Countries

China

Contacts

Public ContactXiaodong Zhu
zxd3516@tmu.edu.cn+86 13312142939

Outcome results

None listed

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