CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Deep Brain Stimulation (DBS) at 60 Hz +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/NCT02549859
NCT02549859N/ACompleted

Long-term Effect of Low Frequency 60Hz Stimulation on Aspiration, Freezing of Gait and Other Axial and Motor Symptoms in PD Patients With Bilateral STN DBS

University of Chicago·interventional·Posted Sep 15, 2015·Updated Oct 29, 2020

In Brief

A clinical study evaluating Deep Brain Stimulation (DBS) at 60 Hz, Deep Brain Stimulation (DBS) at 130 Hz, and 1 other intervention for Parkinson's Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson patients with FOG refractory to 130Hz and medications. The benefit of 60Hz stimulation persisted during the 6-week study period, but with worsening tremor in one patient. However, it remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period, and whether there is carry-over effect across different conditions. Hence, the investigators would like to test the hypothesis that the 60Hz stimulation, compared to 130Hz might have persistent benefit over an extended period in reducing the swallowing dysfunction, FOG, and other axial symptoms in these PD patients even after correcting the potential carry-over effect.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.8 years ago

Interventions

Deep Brain Stimulation (DBS) at 60 Hzdevice

Bilateral subthalamic nucleus deep brain stimulation at 60 Hz

Deep Brain Stimulation (DBS) at 130 Hzdevice

Bilateral subthalamic nucleus deep brain stimulation at 130 Hz

Deep Brain Stimulation (DBS) Off (Sham)device

Deep Brain Stimulation (DBS) Off (Sham)