Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency
NCT ID: NCT04383665
Last Updated: 2021-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-01-31
2020-03-03
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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STN DBS off
STN DBS off
Existing DBS device turned off
STN DBS 10Hz
STN DBS 10Hz
Stimulation of existing DBS device at 100Hz, with other parameters at baseline
STN DBS 130Hz
STN DBS 130Hz
Stimulation of existing DBS device at 130Hz, with other parameters at baseline
Interventions
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STN DBS 10Hz
Stimulation of existing DBS device at 100Hz, with other parameters at baseline
STN DBS 130Hz
Stimulation of existing DBS device at 130Hz, with other parameters at baseline
STN DBS off
Existing DBS device turned off
Eligibility Criteria
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Inclusion Criteria
2. Age \>18 years old
3. Stable medication regimen for at least 3 months.
4. Patient informed and able to give written consent
5. Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria
2. History of major substance abuse
3. Patients with baseline settings at less than 1.5 V will be excluded from the study
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Darrin J Lee, MD, PhD
Assistant Professor of Neurosurgery
Principal Investigators
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Darrin J Lee, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Keck hospital of the University of Southern California
Los Angeles, California, United States
Countries
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References
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Evans FJ. Monitoring attention deployment by random number generation: An index to measure subjective randomness. Bull Psychon Soc 1978;12:35-8.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Other Identifiers
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HS-19-00518
Identifier Type: -
Identifier Source: org_study_id
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