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Trial Outcomes & Findings for Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease (NCT NCT03204526)

NCT ID: NCT03204526

Last Updated: 2021-06-23

Results Overview

The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

2 days

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure
Low Frequency Stimulation (LFS)
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
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
Low Frequency Stimulation (LFS)
n=15 Participants
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Age, Continuous
62.18 Year
STANDARD_DEVIATION 6.42 • n=15 Participants
Sex: Female, Male
Female
2 Participants
n=15 Participants
Sex: Female, Male
Male
13 Participants
n=15 Participants
Disease Duration
7.73 Year
STANDARD_DEVIATION 3.38 • n=15 Participants

PRIMARY outcome

Timeframe: 2 days

The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

Outcome measures

Outcome measures
Measure
Low Frequency Stimulation (LFS)
n=15 Participants
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Mean Reaction Time for Computerized Color Naming Stroop Task
5.09 seconds
Interval 2.0 to 18.0

PRIMARY outcome

Timeframe: 2 days

The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.

Outcome measures

Outcome measures
Measure
Low Frequency Stimulation (LFS)
n=15 Participants
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
4.61 percent correct response
Interval 2.0 to 20.0

SECONDARY outcome

Timeframe: 2 days

Questionnaire with numerical score indicating level of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity.

Outcome measures

Outcome measures
Measure
Low Frequency Stimulation (LFS)
n=10 Participants
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Number of Participants With Worsening Depression Using Beck's Depression Index
0 Participants

SECONDARY outcome

Timeframe: 2 days

The UPDRS scale is a rating tool used to gauge the course of Parkinson's disease in patients and consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.

Outcome measures

Outcome measures
Measure
Low Frequency Stimulation (LFS)
n=15 Participants
Low-frequency deep brain stimulation of the subthalamic nucleus deep brain stimulation
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
0 Participants

Adverse Events

Low Frequency Stimulation (LFS)

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

Kiarash Shahlaie, MD, PhD, FAANS, Bronte Professor of Neurological Surgery

UC Davis Health

Phone: 916-734-6342

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place