- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937688
Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
October 18, 2022 updated by: MedtronicNeuro
Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
To gather data on DBS Therapy effectiveness in different geographic populations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
212
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belo Horizonte, Brazil, 30150-221
- Santa Casa de Misericórdia de Belo Horizonte
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Salvador, Brazil, 41253-190
- Hospital Sao Rafael - Monte Tabor
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Sao Paulo, Brazil, 01060-970
- Hospital das Clinicas de Sao Paulo/ IPQ
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São José do Rio Preto, Brazil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, Brazil, 04037-003
- SPDM- Hospital Sao Paulo
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São Paulo, Brazil, 08270-070
- Hospital Santa Marcelina
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Parana
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Curitiba, Parana, Brazil, 80050-350
- Hospital Universitario Cajuru
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Beijing, China, 100053
- Xuanwu Hospital Capital Medical University
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Chengdu, China, 610041
- HuaXi hospital
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Guangzhou, China, 510080
- The First Affiliated Hospital of Sun Yat-sen University
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Shanghai, China
- Huashan Hospital
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Shanghai, China, 200025
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine
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Shenyang, China, 110001
- The First Hospital of China Medical University
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Xi'an, China, 710038
- Tangdu Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.
Description
Inclusion Criteria:
- Indication of DBS for PD consistent with the country specific approved labeling.
- Levodopa-responsive Parkinson's disease (UPDRS III ≥ 30% improvement on Levodopa challenge test).
- Symptoms treatable by medications but not adequately controlled with medications (with persistent disabling symptoms, such as motor fluctuations, dyskinesia).
- At least 22 years old.
- 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.
- 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:
- Secondary Parkinson's disease, atypical syndromes.
- Previous stereotactic functional neurosurgery or ablative therapy (e.g., pallidotomy, subthalamotomy), surgical contraindications related to DBS.
- 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.
- Electrical or electromagnetic implant (e.g., Cochlear prosthesis, cardiac pacemaker).
- Surgical or medical contraindications to DBS surgery or therapy (e.g., uncontrolled hypertension, advanced coronary artery disease).
- Participation in a drug, device, or biologics trial within the preceding 30 days that may confound the study results.
- Pregnant female.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication
Time Frame: Baseline to 12 months
|
Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2017
Primary Completion (Actual)
July 30, 2021
Study Completion (Actual)
July 30, 2021
Study Registration Dates
First Submitted
October 17, 2016
First Submitted That Met QC Criteria
October 17, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
October 20, 2022
Last Update Submitted That Met QC Criteria
October 18, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1678
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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