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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication on state.

Locations
United States
Illinois
University of Chicago, Department of Neurology
Chicago
Time Frame
Start Date: 2015-08
Completion Date: 2017-05
Participants
Target number of participants: 11
Treatments
Experimental: Deep Brain Stimulation (DBS)
All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Chicago
Collaborators: Michael J. Fox Foundation for Parkinson's Research

This content was sourced from clinicaltrials.gov