Vercise™ DBS Dystonia Prospective Study

Boston Scientific

Status: Enrolling

Conditions: Dystonia

Treatments: Device: Deep Brain Stimulation (DBS)

Study type: Observational

Funder types: Industry

Identifiers

NCT02686125

A4012

Details and patient eligibility

About

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Full description

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed.

Enrollment: 300 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (IC):

• IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia.
• IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.

Exclusion Criteria (EC):

• EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.