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Trial record 25 of 2447 for:    parkinson's

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

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ClinicalTrials.gov Identifier: NCT02937688
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief Summary:
To gather data on DBS Therapy effectiveness in different geographic populations.

Condition or disease Intervention/treatment
Parkinson Disease Device: Medtronic DBS Therapy for Parkinson's disease

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
Estimated Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Medtronic DBS Therapy for Parkinson's disease
    Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
    Other Name: Medtronic Activa DBS System


Primary Outcome Measures :
  1. 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 ]
  2. Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication [ Time Frame: Baseline to 12 months ]


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937688


Contacts
Contact: REACH-PD Clinical Research Study Team 763-514-4000 rs.reachpd@medtronic.com

Locations
Brazil
Hospital Universitário Cajuru Recruiting
Curitiba, Parana, Brazil, 80050-350
Contact: Alexandre Novicki Francisco         
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Carlos Roberto de Mello Rieder         
Santa Casa de Misericordia de Belo Horizonte Recruiting
Belo Horizonte, Brazil, 30150-221
Contact: Marcello Penholate Faria         
Hospital Sao Rafael - Monte Tabor Recruiting
Salvador, Brazil, 41253-190
Contact: Yuri Mascarenhas de Andrade Souza         
Hospital Santa Marcelina Recruiting
São Paulo, Brazil, 08270-070
Contact: Fabio Luiz Franceschi Godinho         
China
Xuanwu Hospital Capital Medical University Active, not recruiting
Beijing, China, 100053
Huaxi Hospital Recruiting
Chengdu, China, 610041
Contact: Huifang Shang         
The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, China, 510080
Contact: Ling Chen         
Ruijin Hospital Shanghai Jiao Tong University School of Medicine Active, not recruiting
Shanghai, China, 200025
Huashan Hospital Recruiting
Shanghai, China
Contact: Site Coordinator         
The First Hospital of China Medical University Recruiting
Shenyang, China, 110001
Contact: Xiaoguang Luo         
Tangdu Hospital Recruiting
Xi'an, China, 710038
Contact: Xuelian Wang         
Sponsors and Collaborators
MedtronicNeuro

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT02937688     History of Changes
Other Study ID Numbers: 1678
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MedtronicNeuro:
Parkinson's disease
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases