Predictive Value of Multimodal MRI in Parkinson's Disease
NCT ID: NCT05003206
Last Updated: 2021-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-06-19
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
NCT05992701
Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment
NCT06090682
MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
NCT04996992
Deep Brain Stimulation on Dual-task Gait Performance in PD
NCT05314322
Deep Brain Stimulation for Visuomotor Function in Parkinson's Disease
NCT05400499
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PD,DBS
Patients with idiopathic PD before and after DBS surgery
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.
Deep Brain Stimulation
For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Deep Brain Stimulation
For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese PLA General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xin Lou
Deputy Director of Department of Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xin Lou
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Multimodal MRI DBS-PD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.