Status:
UNKNOWN
Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Parkinson Disease
Depression
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Depressive symptoms are common non-motor symptoms in patients with Parkinson's disease and seriously affect the quality of life and prognosis of patients. Currently, treatment measures for patients wi...
Eligibility Criteria
Inclusion
- 1\. Patients between 18 and 85 years of age with idiopathic PD (diagnosed as "confirmed PD" or "likely PD" according to the 2015 MDS Parkinson's diagnostic criteria), regardless of gender.
- 2\. Meet the DSM-IV diagnostic criteria for depressive episodes. 3. If there is a combination of anti-Parkinsonian medications, the anti-Parkinsonian medication regimen and dose must remain stable for ≥ 28 days and be maintained at that dose for the duration of treatment.
- 4\. Not taking any antidepressant medication for the last 2 months. 5. the subject/their legal representative is able to comply with the study protocol and visit schedule.
- 6\. The patient or his/her legal guardian agrees to participate in this trial and signs an informed consent form.
Exclusion
- 1\. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superimposed syndrome.
- 2\. PD patients with persistent head tremor. 3. Dementia. 4. Patients with suicidal tendencies and psychotic symptoms. 5. Patients with consciousness disorders, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack and other severe organic diseases within 1 year prior to screening (Visit 1) 6. Have contraindications to rTMS(e.g., implantation of cochlear implants, deep brain stimulation, pacemakers, medical pumps, and other metal-containing devices near stimulation coils; history of epilepsy; history of traumatic brain injury, brain tumor, encephalitis, cerebrovascular disease, cerebral metabolic disease; sleep deprivation, unrecovered jet lag, intoxication, overexertion; pregnancy; severe or recent heart disease, etc.) 7. Have contraindications to MRI scanning (including metal implants, retractors, braces, or claustrophobia).
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04707378
Start Date
December 30 2020
End Date
December 31 2021
Last Update
January 13 2021
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080