Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05003206
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Multimodal MRI in Parkinson's Disease
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Multimodal Magnetic Resonance Imaging Studying the Mechanism and Predicting the Outcome After Deep Brain Stimulation in Patients With Parkinson's Disease
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Deep brain stimulation (DBS) is recognized as the most safe and effective neurosurgical method for the treatment of advanced Parkinson's disease. However, the mechanism of relieving motor and non-motor symptoms of Parkinson's disease has not been fully clarified, and the prognosis is significantly different. This study is based on multimodal MRI technique to clarify the mechanism of DBS in relieving motor and non-motor symptoms of Parkinson's disease, and to explore imaging indicators that can predict prognosis, so as to guide the individual and accurate treatment of Parkinson's disease (PD).
Detailed Description:
1. Preoperative and postoperative multimodal MRI scanning 1) equipment: 3TGE 750 MRI 2) sequence: resting state fMRI, DTI, 3DTI, ESWAN, ASL 3) scan status: drug shutdown period ( discontinuation of drugs for Parkinson's disease for at least 12 hours), for patients who can not adhere to MRI scanning after drug withdrawal. Record the dosage of drugs before scanning
2. Evaluation of motor and non-motor symptoms: pre-operation and 1-year post-operation 1) motor symptoms: pre-operation medication opening and closing period. Postoperative medication off/stimulation off (Med-OFF/DBS-OFF);Med-ON/DBS-OFF;Med-OFF/DBS-ON;Med-ON/DBS-ON
1. overall evaluation of motor function: MDS-UPRDS, H\&Y stage
2. balance: Berg balance scale
3. dyskinesia: abnormal involuntary movement scale(AIMS)
4. end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire
5. daily activity ability: SCHWAB\&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening
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1. Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA)
2. emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA)
3. Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK)
4. pain: King Parkinson's disease pain scale (KPPS)
5. fatigue: fatigue severity scale (FSS)
6. autonomic nervous function assessment: autonomic nervous scale (SCOPA-AUT) h) quality of life: 39 items Parkinson's disease quality of life questionnaire (PDQ-39) 3.other records: changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)
2. Evaluation of motor and non-motor symptoms: pre-operation and 1-year post-operation 1) motor symptoms: pre-operation medication opening and closing period. Postoperative medication off/stimulation off (Med-OFF/DBS-OFF);Med-ON/DBS-OFF;Med-OFF/DBS-ON;Med-ON/DBS-ON
1. overall evaluation of motor function: MDS-UPRDS, H\&Y stage
2. balance: Berg balance scale
3. dyskinesia: abnormal involuntary movement scale(AIMS)
4. end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire
5. daily activity ability: SCHWAB\&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening
<!-- -->
1. Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA)
2. emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA)
3. Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK)
4. pain: King Parkinson's disease pain scale (KPPS)
5. fatigue: fatigue severity scale (FSS)
6. autonomic nervous function assessment: autonomic nervous scale (SCOPA-AUT) h) quality of life: 39 items Parkinson's disease quality of life questionnaire (PDQ-39) 3.other records: changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: