Cognitive Impairment, Parkinson Disease
Conditions
Brief summary
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. In this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.
Detailed description
In this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 Hz), and gamma (130 Hz) frequency stimulation in the ventral STN on cognitive control in patients with PD. This study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of DBS for non-motor symptoms of PD and other neuropsychiatric disorders.
Interventions
DEVICEdeep brain stimulation
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Reaction Time for Computerized Color Naming Stroop Task | 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. |
| Mean Accuracy Rates Using Computerized Color Naming Stroop Task | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worsening Depression Using Beck's Depression Index | 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. |
| Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Frequency Stimulation (LFS) Low-frequency deep brain stimulation of the subthalamic nucleus
deep brain stimulation | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Low Frequency Stimulation (LFS) | — |
|---|---|---|
| Age, Continuous | 62.18 Year STANDARD_DEVIATION 6.42 | — |
| Disease Duration | 7.73 Year STANDARD_DEVIATION 3.38 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
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.
Time frame: 2 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Frequency Stimulation (LFS) | Mean Accuracy Rates Using Computerized Color Naming Stroop Task | 4.61 percent correct response |
Primary
Mean Reaction Time for Computerized Color Naming Stroop Task
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.
Time frame: 2 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Frequency Stimulation (LFS) | Mean Reaction Time for Computerized Color Naming Stroop Task | 5.09 seconds |
Secondary
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
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.
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Frequency Stimulation (LFS) | Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III) | 0 Participants |
Secondary
Number of Participants With Worsening Depression Using Beck's Depression Index
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.
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Frequency Stimulation (LFS) | Number of Participants With Worsening Depression Using Beck's Depression Index | 0 Participants |