Parkinson's Disease
Conditions
Brief summary
To evaluate DBS device settings and match with the features of the DBS care management software.
Detailed description
This is a study done on Parkinson disease subjects who have received the DBS system implanted in their subthalamic nucleus.
Interventions
DEVICEMedtronic DBS system
Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.
Sponsors
MedtronicNeuro
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap | 18 months | The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores | Change from baseline to 18 months | The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108. |
Countries
United States
Participant flow
Pre-assignment details
Following enrollment but prior to analysis, MRIs were evaluated for readability. Those unreadable were excluded from analysis (N=3).
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Advanced Parkinson's Disease Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unreadable Images | 3 |
Baseline characteristics
| Characteristic | Subjects With Advanced Parkinson's Disease |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
| UPDRS III scores at baseline | 39.4 units on a scale STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap
The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.
Time frame: 18 months
Population: Per Protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PD Patients Implanted With DBS System | To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap | 86.5 percentage of leads |
Comparison: A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.
Secondary
Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores
The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.
Time frame: Change from baseline to 18 months
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PD Patients Implanted With DBS System | Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores | -22.5 units on a scale | Standard Deviation 8.7 |
Comparison: Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.95% CI: [-26.5, -18.4]