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Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS

NCT02549859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-10-29

Study results available
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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.

Conditions

Interventions

DEVICE

Deep Brain Stimulation (DBS) at 60 Hz

Bilateral subthalamic nucleus deep brain stimulation at 60 Hz

DEVICE

Deep Brain Stimulation (DBS) at 130 Hz

Bilateral subthalamic nucleus deep brain stimulation at 130 Hz

DEVICE

Deep Brain Stimulation (DBS) Off (Sham)

Deep Brain Stimulation (DBS) Off (Sham)

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • University of Chicago

    lead OTHER

Principal Investigators

  • Tao Xie, MD PhD · Department of Neurology, University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549859 on ClinicalTrials.gov