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NCT03800108: FREQUENCY

Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS

Terminated NA Results posted Last updated 5 February 2025
What this trial tests

NA trial testing Personalized DBS adjustments in Parkinson Disease in 5 participants. Terminated before completion.

Timeline
30 May 2018
Primary endpoint
14 January 2020
14 January 2020

Quick facts

Lead sponsorDarlene Floden
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment5
Start date30 May 2018
Primary completion14 January 2020
Estimated completion14 January 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Darlene Floden

Who can join

Adults 40 to 70, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reaction Time Primary · 30-60 minutes after stimulation adjustment

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'

GroupValue95% CI
Personalized DBS Adjustments2
Personalized DBS Adjustments1
Verbal Fluency Primary · 30-60 minutes after stimulation adjustment

Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'

Change at Dorsal High Hz
GroupValue95% CI
Personalized DBS Adjustments6.32 – 11
Change at Ventral Low Hz
GroupValue95% CI
Personalized DBS Adjustments-0.3-5 – 5
Finger Tapping Speed Primary · 30-60 minutes after stimulation adjustment

Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'

Taps change at Dorsal High Hz
GroupValue95% CI
Personalized DBS Adjustments2.1-1 – 5
Taps change at Ventral Low Hz
GroupValue95% CI
Personalized DBS Adjustments2.2.66 – 4.5

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03800108.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing