Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
NCT03204526, Not applicable, Completed, University of California, Davis; results first posted 2021-06-23
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT03204526 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of California, Davis | ClinicalTrials.gov |
| Conditions | Parkinson Disease, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | deep brain stimulation | ClinicalTrials.gov |
| First posted | 2017-07-02 | ClinicalTrials.gov |
| Last updated | 2021-06-23 | ClinicalTrials.gov |
| Results first posted | 2021-06-23 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Mean Reaction Time for Computerized Color Naming Stroop Task | 2 days | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | Mean Accuracy Rates Using Computerized Color Naming Stroop Task | 2 days | percent correct response | MEAN | ClinicalTrials.gov | |
| SECONDARY | Number of Participants With Worsening Depression Using Beck's Depression Index | 2 days | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III) | 2 days | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
Results by group 4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Mean Reaction Time for Computerized Color Naming Stroop Task | Low Frequency Stimulation (LFS) | 5.09 | 95% Confidence Interval 2 to 18 | seconds | ClinicalTrials.gov | |
| Mean Accuracy Rates Using Computerized Color Naming Stroop Task | Low Frequency Stimulation (LFS) | 4.61 | 95% Confidence Interval 2 to 20 | percent correct response | ClinicalTrials.gov | |
| Number of Participants With Worsening Depression Using Beck's Depression Index | Low Frequency Stimulation (LFS) | 0 | Participants | ClinicalTrials.gov | ||
| Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III) | Low Frequency Stimulation (LFS) | 0 | Participants | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Low Frequency Stimulation (LFS) | 15 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Low Frequency Stimulation (LFS) | 15 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Low Frequency Stimulation (LFS) | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Low Frequency Stimulation (LFS) | 0 | 15 | ClinicalTrials.gov |
| Total, other adverse events | Low Frequency Stimulation (LFS) | 0 | 15 | ClinicalTrials.gov |
| Total, serious adverse events | Low Frequency Stimulation (LFS) | 0 | 15 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)