Deep Brain Stimulation (DBS) for Parkinson's Disease International Study
NCT ID: NCT02937688
Last Updated: 2022-10-20
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
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COMPLETED
212 participants
OBSERVATIONAL
2017-07-26
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Medtronic DBS Therapy for Parkinson's disease
Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Locations
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Hospital Universitário Cajuru
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital Sao Rafael - Monte Tabor
Salvador, , Brazil
Hospital de Base de São Jose do Rio Preto
São José do Rio Preto, , Brazil
Hospital das Clinicas de Sao Paulo/ IPQ
São Paulo, , 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
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Huashan Hospital
Shanghai, , China
The First Hospital of China Medical University
Shenyang, , China
Tangdu Hospital
Xi'an, , China
Countries
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References
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Zhang Y, Chen L, Sun B, Wang X, Wang J, Wang J, Woods J, Stromberg K, Shang H. Quality of Life and Motor Outcomes in Patients With Parkinson's Disease 12 Months After Deep Brain Stimulation in China. Neuromodulation. 2023 Feb;26(2):443-450. doi: 10.1016/j.neurom.2022.10.047. Epub 2022 Nov 18.
Other Identifiers
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1678
Identifier Type: -
Identifier Source: org_study_id
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