Parkinson Disease
Conditions
Keywords
Parkinson's disease, Deep Brain Stimulation
Brief summary
To gather data on DBS Therapy effectiveness in different geographic populations.
Detailed description
The purpose of this prospective open label post market study of DBS for PD is to gather data on DBS therapy effectiveness as measured by clinician and patient reported health outcomes data through one year of follow-up in different geographic populations.
Interventions
DEVICEMedtronic DBS Therapy for Parkinson's disease
Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
Sponsors
MedtronicNeuro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Indication of DBS for PD consistent with the country specific approved labeling. 2. Levodopa-responsive Parkinson's disease (UPDRS III ≥ 30% improvement on Levodopa challenge test). 3. Symptoms treatable by medications but not adequately controlled with medications (with persistent disabling symptoms, such as motor fluctuations, dyskinesia). 4. At least 22 years old. 5. Screening cranial MRI, performed within 12 months of entry into the study, that is normal or with a non-significant abnormality that does not present any incremental risks or concerns for the patient as a result of the DBS procedure. 6. Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
Exclusion criteria
1. Secondary Parkinson's disease, atypical syndromes. 2. Previous stereotactic functional neurosurgery or ablative therapy (e.g., pallidotomy, subthalamotomy), surgical contraindications related to DBS. 3. Dementia (Mattis Dementia Rating Scale ≤ 130), major depression with suicidal thoughts (Beck Depression Inventory II \> 25), acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigator's medical judgment. 4. Electrical or electromagnetic implant (e.g., Cochlear prosthesis, cardiac pacemaker). 5. Surgical or medical contraindications to DBS surgery or therapy (e.g., uncontrolled hypertension, advanced coronary artery disease). 6. Participation in a drug, device, or biologics trial within the preceding 30 days that may confound the study results. 7. Pregnant female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8). | Baseline to 12 months |
| Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication | Baseline to 12 months |
Countries
Brazil, China
Outcome results
None listed