Deep Brain Stimulation (DBS) for Parkinson's Disease International Study
REACH-PD
1 other identifier
observational
212
2 countries
15
Brief Summary
To gather data on DBS Therapy effectiveness in different geographic populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedOctober 20, 2022
October 1, 2022
4 years
October 17, 2016
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Interventions
Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
Eligibility Criteria
Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (15)
Hospital Universitário Cajuru
Curitiba, Paraná, 80050-350, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Hospital Sao Rafael - Monte Tabor
Salvador, 41253-190, Brazil
Hospital de Base de São Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Hospital das Clinicas de Sao Paulo/ IPQ
São Paulo, 01060-970, Brazil
SPDM- Hospital Sao Paulo
São Paulo, 04037-003, Brazil
Hospital Santa Marcelina
São Paulo, 08270-070, Brazil
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Huaxi Hospital
Chengdu, 610041, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510080, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Huashan Hospital
Shanghai, China
The First Hospital of China Medical University
Shenyang, 110001, China
Tangdu Hospital
Xi'an, 710038, China
Related Publications (1)
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.
PMID: 36411150DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 18, 2016
Study Start
July 26, 2017
Primary Completion
July 30, 2021
Study Completion
July 30, 2021
Last Updated
October 20, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share