Predictive Value of Multimodal MRI in Parkinson's Disease

NCT05003206 | Unknown

• 1 other identifier: Multimodal MRI DBS-PD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Subthalamic nucleus deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• other records:

  1 to 3 years

Study Arms (1)

PD,DBS

EXPERIMENTAL

Patients with idiopathic PD before and after DBS surgery

Other: Functional magnetic resonance imaging; Device: Deep Brain Stimulation

Interventions

Functional magnetic resonance imaging OTHER

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.

PD,DBS

Deep Brain Stimulation DEVICE

For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan

PD,DBS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Xin Lou

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Yina Lan

CONTACT

+86-17326826301; lanyn1220@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Radiology

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 12, 2021
• Study Start: June 19, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)