Coordinated Reset Deep Brain Stimulation (RESET-DBS)

Boston Scientific

Status: Completed

Conditions: Parkinson's Disease (PD)

Treatments: Device: Conventional Programming (cDBS); Device: Novel Programming (nDBS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03732898

A4058

Details and patient eligibility

About

The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Full description

The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
2. Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

1. Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Novel Deep Brain Stimulation (nDBS) program

Experimental group

Description:

This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD).

Treatment:

Device: Novel Programming (nDBS)

Conventional Deep Brain Stimulation (cDBS) program

Active Comparator group

Description:

This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD).

Treatment:

Device: Conventional Programming (cDBS)