Predictive Value of Multimodal MRI in Parkinson's Disease

August 10, 2021 updated by: Xin Lou, Chinese PLA General Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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
    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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD,DBS
Patients with idiopathic PD before and after DBS surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of patients
Time Frame: 1 to 2 years
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
Percentage of improvement in motor aspects (after 12 months of stimulation)
Time Frame: 1 to 3 years
(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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
other records:
Time Frame: 1 to 3 years
Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)
1 to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Xin Lou, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Multimodal MRI DBS-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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