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NCT02549859 · ClinicalTrials.gov registry record · NA
Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
A NA study, sponsored by University of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT02549859 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 11 participants.
The verdict
NCT02549859, a NA study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Deep Brain Stimulation (DBS) at 60 Hz
- DEVICE Deep Brain Stimulation (DBS) at 130 Hz
- DEVICE Deep Brain Stimulation (DBS) Off (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02549859
The ClinicalTrials.gov registry entry for NCT02549859 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Deep Brain Stimulation (DBS) at 60 Hz is the first listed.
NCT02549859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02549859 about?
NCT02549859 is a clinical study titled "Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS". 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...
What is the current status of trial NCT02549859?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2015-08. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02549859?
The interventions under investigation include: Deep Brain Stimulation (DBS) at 60 Hz (DEVICE), Deep Brain Stimulation (DBS) at 130 Hz (DEVICE), Deep Brain Stimulation (DBS) Off (Sham) (DEVICE).
Who is sponsoring clinical trial NCT02549859?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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