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

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: Parkinson Disease
• Intervention / Treatment: 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
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Santa Casa de Misericórdia de Belo Horizonte
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael - Monte Tabor
  • Sao Paulo, Brazil, 01060-970
    • Hospital das Clinicas de Sao Paulo/ IPQ
  • São José do Rio Preto, Brazil, 15090-000
    • Hospital de Base de Sao Jose do Rio Preto
  • São Paulo, Brazil, 04037-003
    • SPDM- Hospital Sao Paulo
  • São Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • Parana
    • Curitiba, Parana, Brazil, 80050-350
      • Hospital Universitario Cajuru
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
• China
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University
  • Chengdu, China, 610041
    • HuaXi hospital
  • Guangzhou, China, 510080
    • The First Affiliated Hospital of Sun Yat-sen University
  • Shanghai, China
    • Huashan Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
  • Shenyang, China, 110001
    • The First Hospital of China Medical University
  • Xi'an, China, 710038
    • Tangdu Hospital

Participation Criteria

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:

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.

Study Plan

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).	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

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

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

• Keywords: Deep Brain Stimulation; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No