Precision Therapy of Parkinson’s Disease Using 3T MRI-Compatible Deep Brain Stimulation

Integrating FDOPA PET Imaging for Intelligent Diagnosis and 3T MRI-Compatible DBS for Precision Treatment in Parkinson's Disease

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600120188

Enrollment

Unknown

Registered

2026-03-10

Start date

2024-01-10

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Parkinson’s Disease Patient Group:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years, with a diagnosis of idiopathic Parkinson’s disease according to the MDS clinical diagnostic criteria; 2. Disease duration of at least 5 years; 3. Markedly reduced therapeutic response to oral antiparkinsonian medications; 4. Presence of intolerable medication-related adverse effects; 5. No severe concomitant medical or neurological comorbidities; 6. Improvement of >=30% on the levodopa challenge test; 7. Undergoing bilateral STN-DBS implantation using the domestically developed PINS G106R/RS 3T MRI-compatible DBS system; 8. Ability and willingness of the patient and their legal guardians to provide written informed consent and to comply with follow-up assessments.

Exclusion criteria

Exclusion criteria: 1. Presence of significant cognitive impairment or severe psychiatric disorders; 2. Severe tremor or dyskinesia resulting in excessive head motion and compromised MRI data quality; 3. Implantation of the implantable pulse generator in the left subclavicular region; 4. Contraindications to MRI or inability to tolerate repeated MRI examinations; 5. MRI evidence of marked white matter abnormalities, vascular malformations, or other structural brain lesions; 6. Severe metal-related artifacts interfering with image analysis; 7. Significant deviation of electrode placement from the intended target associated with suboptimal postoperative clinical efficacy; 8. MRI scans acquired on different scanners or imaging platforms.

Design outcomes

Primary

Measure	Time frame
Resting-State Functional Magnetic Resonance Imaging;Diffusion Kurtosis Imaging;	—

Secondary

Measure	Time frame
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III;T1-weighted imaging;	—

Countries

China

Contacts

Public ContactChen Ling

The First Affiliated Hospital, Sun Yat-sen University

chenl2@mail.sysu.edu.cn+86 135 4343 3955

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026