An interventional study of Personalized DBS adjustments in Parkinson Disease, sponsored by Darlene Floden. Terminated at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Darlene Floden · Not applicable, Interventional, and Other
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Darlene Floden as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Hearing or visual impairment precluding cognitive testing.
Exclusion criteria for Day 2 procedures:
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Procedure: Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
Reaction Time
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
Verbal Fluency
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
Finger Tapping Speed
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
Time frame: 30-60 minutes after stimulation adjustment
Five participants were enrolled from 05/30/2018 to 11/04/2019.
| Milestone | Personalized DBS Adjustments |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
| Participants | Personalized DBS Adjustments |
|---|---|
| Inhibitory control worse with Ventral High Hz | 2 |
| Inhibitory control worse with Dorsal Low Hz | 1 |
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
| words | Personalized DBS Adjustments |
|---|---|
| Change at Dorsal High Hz | 6.3 (2 to 11) |
| Change at Ventral Low Hz | -0.3 (-5 to 5) |
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
| finger taps | Personalized DBS Adjustments |
|---|---|
| Taps change at Dorsal High Hz | 2.1 (-1 to 5) |
| Taps change at Ventral Low Hz | 2.2 (.66 to 4.5) |
Collected over Adverse event data were collected for 2-3 days, depending on the number of study sessions, with monitoring by Clinical Research Unit (CRU) nursing staff and the research team. Participants were assessed for safety and well-being after each change in stimulation parameters during EEG recording and fMRI sessions as well as by telephone one day after their final study session.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized DBS Adjustments | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Personalized DBS Adjustments |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 4 |
| Age, Continuous(years) | Personalized DBS Adjustments |
|---|---|
| Mean | 68.4 ± 1.9 |
| Sex: Female, Male(Participants) | Personalized DBS Adjustments |
|---|---|
| Female | 0 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Personalized DBS Adjustments |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Personalized DBS Adjustments |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Personalized DBS Adjustments |
|---|---|
| United States | 5 |
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