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Predictive Value of Multimodal MRI in Parkinson's Disease

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Functional magnetic resonance imaging
Deep Brain Stimulation
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Subthalamic nucleus deep brain stimulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD,DBS

Arm Description

Patients with idiopathic PD before and after DBS surgery

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

other records:
Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)

Full Information

First Posted
July 1, 2021
Last Updated
August 10, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05003206
Brief Title
Predictive Value of Multimodal MRI in Parkinson's Disease
Official Title
Multimodal Magnetic Resonance Imaging Studying the Mechanism and Predicting the Outcome After Deep Brain Stimulation in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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 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 overall evaluation of motor function: MDS-UPRDS, H&Y stage balance: Berg balance scale dyskinesia: abnormal involuntary movement scale(AIMS) end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire daily activity ability: SCHWAB&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA) emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA) Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK) pain: King Parkinson's disease pain scale (KPPS) fatigue: fatigue severity scale (FSS) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Magnetic Resonance Imaging, Deep Brain Stimulation
Keywords
Subthalamic nucleus deep brain stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD,DBS
Arm Type
Experimental
Arm Description
Patients with idiopathic PD before and after DBS surgery
Intervention Type
Other
Intervention Name(s)
Functional magnetic resonance imaging
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan
Primary Outcome Measure Information:
Title
Clinical characteristics of patients
Description
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
Time Frame
1 to 2 years
Title
Percentage of improvement in motor aspects (after 12 months of stimulation)
Description
(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
Time Frame
1 to 3 years
Secondary Outcome Measure Information:
Title
other records:
Description
Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)
Time Frame
1 to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yina Lan
Phone
+86-17326826301
Email
lanyn1220@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Lou
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-na Lan
Phone
+86-17326826301
Email
lanyn1220@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Predictive Value of Multimodal MRI in Parkinson's Disease

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