Trial Outcomes & Findings for Pilot Study for Automated Deep Brain Stimulation Programming (NCT NCT02046863)

Results Overview

Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Within two days of standard clinical DBS programming session

Results posted on

2016-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Automated Programming Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study for Automated Deep Brain Stimulation Programming

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Automated Programming n=7 Participants Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Within two days of standard clinical DBS programming session

Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.

Outcome measures

Outcome measures
Measure	Automated Programming n=7 Participants Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting. Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming	-35.7 Percentage change Standard Deviation 37.8

Adverse Events

Automated Programming

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

Biomedical Research Manager

Great Lakes NeuroTechnologies Inc

Phone: 2163615410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60