Parkinson DiseaseREACH-PDNCT02937688
Deep Brain Stimulation (DBS) for Parkinson's Disease International Study
An observational study of Parkinson Disease, run by MedtronicNeuro at 15 sites in 2 countries.
Trial summary
To gather data on DBS Therapy effectiveness in different geographic populations. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Medtronic DBS Therapy for Parkinson's disease
- Type of treatment
- Medical device
- How many people
- 212 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 26 Jul 2017to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Brazil8 sites
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221
Hospital Universitário Cajuru
Curitiba, Paraná, 80050-350
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital Sao Rafael - Monte Tabor
Salvador, 41253-190
Hospital de Base de São Jose do Rio Preto
São José do Rio Preto, 15090-000
Hospital das Clinicas de Sao Paulo/ IPQ
São Paulo, 01060-970
SPDM- Hospital Sao Paulo
São Paulo, 04037-003
Hospital Santa Marcelina
São Paulo, 08270-070
China7 sites
Xuanwu Hospital Capital Medical University
Beijing, 100053
Huaxi Hospital
Chengdu, 610041
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, 510080
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Huashan Hospital
Shanghai
The First Hospital of China Medical University
Shenyang, 110001
Tangdu Hospital
Xi'an, 710038
About this study
Official title: Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
To gather data on DBS Therapy effectiveness in different geographic populations.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Medtronic DBS Therapy for Parkinson's disease
- Keywords
- Parkinson's disease, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic DBS Therapy for Parkinson's diseaseDevice
Also called Medtronic Activa DBS System
Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).
Measured: Baseline to 12 months
Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start26 Jul 2017
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937688
- Sponsor's protocol ID
- 1678
- Acronym
- REACH-PD
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2016
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36411150
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
- ClinicalTrials.gov ID
- NCT02937688
- Acronym / sponsor ID
- REACH-PD / 1678
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic DBS Therapy for Parkinson's diseaseAlso: Medtronic Activa DBS SystemBilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna. | Device | – |
Primary outcome
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
Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 36411150Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by MedtronicNeuro at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Brazil, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.