Deep Brain Stimulation (DBS) for Parkinson's Disease International Study

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT02937688
• Lead Sponsor: MedtronicNeuro

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.

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Study Start: 2017-07-26
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Universitário Cajuru; 🇧🇷 Curitiba, Parana, Brazil

Santa Casa de Misericordia de Belo Horizonte; 🇧🇷 Belo Horizonte, Brazil

Hospital das Clinicas de Sao Paulo/ IPQ; 🇧🇷 Sao Paulo, Brazil

Hospital Sao Rafael - Monte Tabor; 🇧🇷 Salvador, Brazil

Hospital de Base de São Jose do Rio Preto; 🇧🇷 São José do Rio Preto, Brazil

SPDM- Hospital Sao Paulo; 🇧🇷 São Paulo, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, Brazil

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Huaxi Hospital; 🇨🇳 Chengdu, China

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Huashan Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, China

Tangdu Hospital; 🇨🇳 Xi'an, China