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

Parkinson Disease Clinical Trial

— REACH-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937688
• Other study ID #: 1678
• Status: Completed
• Start date: July 26, 2017
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2022
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Hospital Universitário Cajuru	Curitiba	Parana
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Sao Rafael - Monte Tabor	Salvador
Brazil	Hospital de Base de São Jose do Rio Preto	São José do Rio Preto
Brazil	Hospital das Clinicas de Sao Paulo/ IPQ	Sao Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	SPDM- Hospital Sao Paulo	São Paulo
China	Xuanwu Hospital Capital Medical University	Beijing
China	Huaxi Hospital	Chengdu
China	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou
China	Huashan Hospital	Shanghai
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	The First Hospital of China Medical University	Shenyang
China	Tangdu Hospital	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

Brazil,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parkinson's disease-related quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-8).		Baseline to 12 months
Primary	Change in motor score, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III, off medication		Baseline to 12 months