Predictive Value of Multimodal MRI in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Multimodal Magnetic Resonance Imaging Studying the Mechanism and Predicting the Outcome After Deep Brain Stimulation in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003206
• Other study ID #: Multimodal MRI DBS-PD
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2021
• Source: Chinese PLA General Hospital
• Contact: Yina Lan
• Phone: +86-17326826301
• Email: lanyn1220[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with Parkinson's disease

• age< 70 years

• Underwent bilateral STN-DBS or not

• Having complete medical history and clinical follow up

• All MRI examination performed according to study protocol

• Imaging data can be processed

• Signed informed consent obtained from the patient or patient's legally authorized representative;

Exclusion Criteria:

• Parkinson-plus syndrome or secondary parkinsonism

• Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Magnetic Resonance Imaging
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Functional magnetic resonance imaging
Preoperative and postoperative functional magnetic resonance imaging (fMRI) scanning. fMRI is a new neuroimaging method. Its principle is to use magnetic resonance imaging to measure the changes of hemodynamics caused by neuronal activity.

Device:
• Deep Brain Stimulation
For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical characteristics of patients	Age at onset; age at surgery; disease duration; level of education; comorbidities (e.g. hypertension and diabetes mellitus); parkinsonism subtype; period of motor fluctuations; time from motor fluctuations to surgery; cigarette smoking	1 to 2 years
Primary	Percentage of improvement in motor aspects (after 12 months of stimulation)	(UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.The clinical outcome, or degree of symptom benefit, was defined as a =50% improvement on a disease severity rating scale	1 to 3 years
Secondary	other records:	Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)	1 to 3 years