Trial Outcomes & Findings for Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II (NCT NCT07106242)

Results Overview

Comparison of TEED between aDBS and cDBS at aDBS treatment phase (Visit 2 and Visit 3). The TEED was computed using the average stimulation currents from the timeline data during the last 14 days at Visit 2 and Visit 3.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

First 45-day period after the randomization with aDBS or cDBS treatment as randomized, will be compared to the following second 45-day period of aDBS or cDBS treatment.

Results posted on

2026-03-19

Participant Flow

First enrollment: November 29, 2021 Last patient last visit: October 23, 2023 The study was conducted at two sites located in Japan. Participants were either completed the Early Adapter I study, or they had undergone a standard assessment demonstrating their tolerability of aDBS (preferred mode).

Randomization and Treatment Assignment 7 days or more after cDBS has been set and within 30 days after the baseline visit. 25 subjects were randomly assigned during a randomization to either sequence, the first intervention was aDBS then cDBS (aDBS -\> cDBS) or the first intervention was cDBS then aDBS (cDBS -\> aDBS).

Participant milestones

Participant milestones
Measure	aDBS -> cDBS Sequence 1: aDBS then cDBS	cDBS -> aDBS Sequence 2: cDBS then aDBS
First Intervention STARTED	14	11
First Intervention COMPLETED	14	11
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	14	11
Second Intervention COMPLETED	14	11
Second Intervention 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	Total n=25 Participants Patient in Total
Age, Continuous	70.0 years STANDARD_DEVIATION 7.50 • n=25 Participants
Sex: Female, Male Female	14 Participants n=25 Participants
Sex: Female, Male Male	11 Participants n=25 Participants
Region of Enrollment Japan	25 participants n=25 Participants
PD Duration	12.1 years STANDARD_DEVIATION 4.57 • n=25 Participants

PRIMARY outcome

Timeframe: First 45-day period after the randomization with aDBS or cDBS treatment as randomized, will be compared to the following second 45-day period of aDBS or cDBS treatment.

Population: Fourteen patients were randomized to aDBS -\> cDBS treatment sequence and eleven patients were randomized to cDBS -\> aDBS treatment sequence.

Comparison of TEED between aDBS and cDBS at aDBS treatment phase (Visit 2 and Visit 3). The TEED was computed using the average stimulation currents from the timeline data during the last 14 days at Visit 2 and Visit 3.

Outcome measures

Outcome measures
Measure	aDBS n=25 Participants aDBS	cDBS n=25 Participants Continuous DBS
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS) Visit 3 (The average value for the last 14 days of Visit3)	119.6 μWatts Standard Deviation 52.05	119.7 μWatts Standard Deviation 75.78
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS) Visit 2 (The average value for the last 14 days of Visit2)	109.7 μWatts Standard Deviation 69.16	116.8 μWatts Standard Deviation 55.36

SECONDARY outcome

Timeframe: A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment

Population: Patients with secondary endpoints available were included in the analysis.

The secondary objective is to demonstrate maintenance within an optimal beta LFP threshold of beta LFP power during aDBS mode compared to cDBS. The optimal beta LFP threshold indicates values between upper and lower LFP threshold preset for each patient.

Outcome measures

Outcome measures
Measure	aDBS n=22 Participants aDBS	cDBS n=24 Participants Continuous DBS
The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS.	36.3 percentage of time Standard Deviation 21.76	34.4 percentage of time Standard Deviation 23.53

Adverse Events

aDBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

cDBS

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

Clinical Scientist

Medtronic

Phone: +818072283557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place