Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study

Medtronic

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Medtronic DBS system

Study type: Observational

Funder types: Industry

Identifiers

NCT01750242

1669

Details and patient eligibility

About

To evaluate DBS device settings and match with the features of the DBS care management software.

Full description

This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with Medtronic Deep Brain Stimulation therapy for idiopathic levodopa responsive Parkinson's Disease
• Patient who has had lead placement in the Subthalamic nucleus
• Patient with pre-op MRI available
• Patient with post-op CT scan available showing placement of the lead
• Patient who has documented improvement of at least 35% on UPDRS III scores from baseline preoperative off medication state compared to post DBS implant stimulation on/medications off

Exclusion criteria

• Patient who has had clinically significant persistent stimulation related adverse effects
• Patient who has evidence of lead migration without lead revision
• Patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)

Trial design

20 participants in 1 patient group

Parkinson's disease Subjects

Description:

Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system in the subthalamic nucleus (STN).

Treatment:

Device: Medtronic DBS system