Clinical trial NCT02937688: Deep Brain Stimulation (DBS) for Parkinson's Disease International Study
Official title: Deep Brain Stimulation (DBS) for Parkinson's Disease International Study (REACH-PD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Deep Brain Stimulation
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 212
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with levodopa responsive Parkinson's disease that are not adequately controlled by medication.

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).
timeFrame: Baseline to 12 months
measure: Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Universitário Cajuru
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - Monte Tabor
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas de Sao Paulo/ IPQ
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São Jose do Rio Preto
city: São Paulo
country: Brazil
facility: SPDM- Hospital Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chengdu
country: China
facility: Huaxi Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Huashan Hospital
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Xi'an
country: China
facility: Tangdu Hospital
Study officials:
References: