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Rationale: Parkinson's disease patients with deep brain stimulation electrodes represent a unique opportunity to study the influence of basal ganglia on neurocognitive function.
Intervention: Patients' deep brain stimulators will be turned off or on and the frequency will be changed to either theta or gamma.
Objectives: To identify differences in higher cognitive functions with stimulation "on" and "off" and theta versus gamma frequency stimulation.
Study population: 12 patients who had previously undergone bilateral STN deep brain stimulation implantation.
Study methodology: Patients will undergo four sessions of neuropsychological testing (RNGT, verbal fluency, D-KEFS CWIT) at baseline, no stimulation, theta stimulation and gamma stimulation, in random order over one day.
Study outcomes: Test results of RNGT, verbal fluency, D-KEFS CWIT. Follow-up: none
Statistics: Test results will be analyzed using within-subjects statistical tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN DBS off | Sham Comparator |
| |
| STN DBS 10Hz | Experimental |
| |
| STN DBS 130Hz | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN DBS 10Hz | Device | Stimulation of existing DBS device at 100Hz, with other parameters at baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delis-Kaplan Executive Function System Verbal Fluency | Number of words per category in one minute | 5-15 minutes following stimulation frequency setting change. |
| Delis-Kaplan Executive Function System Color Word Interference Task | Time to completion of a color-word interference task | 5-15 minutes following stimulation frequency setting change. |
| Random Number Generation | Listing of 100 numbers at 1 Hz in a random order. Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function. Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function. Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function. Evan's RNG, count score 1 and cou | 5-15 minutes following stimulation frequency setting change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrin J Lee, MD PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck hospital of the University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8. | ||
| 8292327 | Background | Spatt J, Goldenberg G. Components of random generation by normal subjects and patients with dysexecutive syndrome. Brain Cogn. 1993 Nov;23(2):231-42. doi: 10.1006/brcg.1993.1057. | |
| Background | Towse JN, Neil D. Analyzing human random generation behavior: A review of methods used and a computer program for describing performance. Behav Res Methods Instrum Comput 1998;30:583-91. |
| Label | URL |
|---|---|
| RGCalc | View source |
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12 participants, each tested at off, 10 Hz and 130 Hz
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| ID | Title | Description |
|---|---|---|
| FG000 | Off/10 Hz/130 Hz |
|
| FG001 | Off/130 Hz/10 Hz |
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| FG002 | 10 Hz/Off/130 Hz |
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| FG003 | 10 Hz/130 Hz/Off |
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| FG004 | 130 Hz/Off/10 Hz |
|
| FG005 | 130 Hz/10 Hz/Off |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delis-Kaplan Executive Function System Verbal Fluency | Number of words per category in one minute | Posted | Mean | Standard Error | Words per minute | 5-15 minutes following stimulation frequency setting change. |
|
Adverse events were collected over the entire duration of the study, which lasted between 3 and 4 hours. Patients were assessed at a mean of 21.4 (range 7-52) months following bilateral STN DBS insertion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STN DBS Off | STN DBS off: Existing DBS device turned off | 0 |
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Our study did not control for motor state during testing. Our sample population was not fully representative of the worldwide population of patients with PD.
Our study was not designed nor powered to investigate inter-subject differences such as age, time from DBS implantation, education, first language, or motor function.
Unknown is the adequacy of a 5-min period of stimulation prior to each round of neuropsychological testing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Darrin Lee | Keck School of Medicine of University of Southern California | (323) 442-5720 | darrinjl@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | May 5, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2019 | May 3, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007802 | Language |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| STN DBS 130Hz | Device | Stimulation of existing DBS device at 130Hz, with other parameters at baseline |
|
| STN DBS off | Device | Existing DBS device turned off |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary language | Count of Participants | Participants |
|
|
|
| Primary | Delis-Kaplan Executive Function System Color Word Interference Task | Time to completion of a color-word interference task | Posted | Mean | Standard Error | Seconds | 5-15 minutes following stimulation frequency setting change. |
|
|
|
| Primary | Random Number Generation | Listing of 100 numbers at 1 Hz in a random order. Evan's RNG: a measure of disproportion with which one number follows another in a sequence. Scores range from 0 (equal proportion of sequence pairs) to 1 (maximum disproportion of sequence pairs). A higher score indicates a lower randomness and poorer exective function. Count score 1: a measure of propensity to count in steps of 1. The length of each sequence with steps of 1 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 1) to 100000 (all sequences with steps of 1). A higher score indicates lower randomness and poorer exective function. Count score 2: a measure of propensity to count in steps of 2. The length of each sequence with steps of 2 is squared. The total of these is summed. Scores range from 0 (no sequences with steps of 2) to 100000 (all sequences with steps of 2). A higher score indicates lower randomness and poorer exective function. Evan's RNG, count score 1 and cou | Posted | Mean | Standard Error | Index | 5-15 minutes following stimulation frequency setting change. |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | STN DBS 10Hz | STN DBS 10Hz: Stimulation of existing DBS device at 100Hz, with other parameters at baseline | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | STN DBS 130Hz | STN DBS 130Hz: Stimulation of existing DBS device at 130Hz, with other parameters at baseline | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003142 | Communication |
| D001519 | Behavior |
|
| Color-word interference |
|
| Color-word switching |
|
|
| Count score 2 |
|