Trial Outcomes & Findings for Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS (NCT NCT03800108)

Last Updated: 2025-02-05

Results Overview

Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

30-60 minutes after stimulation adjustment

Results posted on

2025-02-05

Participant Flow

Five participants were enrolled from 05/30/2018 to 11/04/2019.

Following enrollment, participants completed a washout period by withholding Parkinson's medications overnight before each study session to reduce confounding effects. EEG electrodes were then applied prior to cognitive and motor testing under varied deep brain stimulation (DBS) parameters. No participants were excluded after enrollment. Key personnel changes led to early study closure, limiting the final data collection.

Participant milestones

Participant milestones
Measure	Personalized DBS Adjustments Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Personalized DBS Adjustments n=5 Participants Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 30-60 minutes after stimulation adjustment

Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'

Outcome measures

Outcome measures
Measure	Personalized DBS Adjustments n=3 Participants Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Reaction Time Inhibitory control worse with Ventral High Hz	2 Participants
Reaction Time Inhibitory control worse with Dorsal Low Hz	1 Participants

PRIMARY outcome

Timeframe: 30-60 minutes after stimulation adjustment

Population: Patients with Deep Brain Stimulation Electrodes implanted to treat Parkinson's disease

Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'

Outcome measures

Outcome measures
Measure	Personalized DBS Adjustments n=3 Participants Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Verbal Fluency Change at Dorsal High Hz	6.3 words Interval 2.0 to 11.0
Verbal Fluency Change at Ventral Low Hz	-0.3 words Interval -5.0 to 5.0

PRIMARY outcome

Timeframe: 30-60 minutes after stimulation adjustment

Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'

Outcome measures

Outcome measures
Measure	Personalized DBS Adjustments n=3 Participants Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Personalized DBS adjustments: Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Finger Tapping Speed Taps change at Dorsal High Hz	2.1 finger taps Interval -1.0 to 5.0
Finger Tapping Speed Taps change at Ventral Low Hz	2.2 finger taps Interval 0.66 to 4.5

Adverse Events

Personalized DBS Adjustments

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

Dr. Darlene Floden

Cleveland Clinic

Phone: 216-444-1298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place