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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chronic Effects of DBS in Parkinson's Disease and Dystonia

NCT01934296

Parkinson's Disease Isolated Dystonia

COMPLETED NA

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

NCT01839396

Parkinson's Disease

COMPLETED NA

Deep Brain Stimulation (DBS) Retrospective Outcomes Study

NCT03664609

Parkinson Disease Essential Tremor Dystonia

RECRUITING

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S

NCT04011449

Parkinson Disease Parkinson

WITHDRAWN NA

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

NCT02709148

Parkinson's Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parkinson's disease Subjects

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

Medtronic DBS system

Intervention Type DEVICE

Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medtronic DBS system

Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No