Trial Outcomes & Findings for Retrospective, Non-significant Risk, Deep Brain Stimulation (DBS) Care Management Software Feasibility Study (NCT NCT01750242)

Results Overview

The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

18 months

Results posted on

2024-06-03

Participant Flow

Following enrollment but prior to analysis, MRIs were evaluated for readability. Those unreadable were excluded from analysis (N=3).

Participant milestones

Participant milestones
Measure	PD Patients Implanted With DBS System Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
Overall Study STARTED	23
Overall Study Readable Images	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	PD Patients Implanted With DBS System Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
Overall Study Unreadable Images	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Advanced Parkinson's Disease n=20 Participants 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.
Age, Continuous	68 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
UPDRS III scores at baseline	39.4 units on a scale STANDARD_DEVIATION 12.2 • n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Per Protocol

The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.

Outcome measures

Outcome measures
Measure	PD Patients Implanted With DBS System n=20 Participants Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap	86.5 percentage of leads

SECONDARY outcome

Timeframe: Change from baseline to 18 months

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	PD Patients Implanted With DBS System n=20 Participants Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores	-22.5 units on a scale Standard Deviation 8.7

Adverse Events

Subjects With Advanced Parkinson's Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Salisbury

Medtronic Neuromodulation

Phone: 763-526-8096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60