CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
STN DBS 10Hz +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04383665
NCT04383665N/ACompleted

Evaluation of Neurocognitive Changes in Parkinson's Disease Patients Following Acute Low Frequency Deep Brain Stimulation

University of Southern California·interventional·Posted May 12, 2020·Updated Jul 15, 2021

In Brief

A clinical study evaluating STN DBS 10Hz, STN DBS 130Hz, and 1 other intervention for Parkinson Disease. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 12, 2020
Enrollment StartJan 31, 2020
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.1 years ago

Interventions

STN DBS 10Hzdevice

Stimulation of existing DBS device at 100Hz, with other parameters at baseline

STN DBS 130Hzdevice

Stimulation of existing DBS device at 130Hz, with other parameters at baseline

STN DBS offdevice

Existing DBS device turned off