Trial Outcomes & Findings for Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation (NCT NCT02835274)

Results Overview

Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Up to 12 months post-implant

Results posted on

2020-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ring Mode Followed by Unrestricted Mode omni-directional stimulation followed by unrestricted Mode stimulation BSC Deep Brain Stimulation System with Directional Lead	Unrestricted Mode Followed by Ring Mode Unrestricted Mode stimulation followed by omni-directional stimulation BSC Deep Brain Stimulation System with Directional Lead
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ring Mode Followed by Unrestricted Mode n=6 Participants omni-directional stimulation followed by unrestricted Mode stimulation BSC Deep Brain Stimulation System with Directional Lead	Unrestricted Mode Followed by Ring Mode n=6 Participants Unrestricted Mode stimulation followed by omni-directional stimulation BSC Deep Brain Stimulation System with Directional Lead	Total n=12 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 9 • n=6 Participants	61 years STANDARD_DEVIATION 6 • n=6 Participants	63.4 years STANDARD_DEVIATION 7.3 • n=12 Participants
Sex: Female, Male Female	1 Participants n=6 Participants	3 Participants n=6 Participants	4 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=6 Participants	3 Participants n=6 Participants	8 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 12 months post-implant

Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state

Outcome measures

Outcome measures
Measure	Ring Mode n=12 Participants BSC Deep Brain Stimulation System with Directional Lead	Unrestricted Mode n=12 Participants BSC Deep Brain Stimulation System with Directional Lead
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase Baseline	21 units on a scale Standard Deviation 11	21 units on a scale Standard Deviation 11
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase End of Randomized Phase	13 units on a scale Standard Deviation 8	16 units on a scale Standard Deviation 10

Adverse Events

Ring Mode

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unrestricted Mode

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

Director of Clinical Sciences

Boston Scientific

Phone: 6619494350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place