Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 75 |
| Updated: | 6/7/2017 |
| Start Date: | August 2015 |
| End Date: | May 2017 |
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
Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that 60Hz stimulation,
compared to the traditional 130Hz, decreased the aspiration frequency and swallowing
difficulty, medication refractory freezing of gait (FOG), and other axial symptoms and
parkinsonism in Parkinson patients with bilateral STN DBS. The benefit of 60Hz stimulation
persisted during the 6-week study period, 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. Clarifying these
questions is essential for the application of 60Hz stimulation chronically and confidently
to treat medication refractory axial symptoms. Hence, the investigators would test the
hypothesis that the 60Hz stimulation, compared to 130Hz, would have persistent benefit over
an extended period (on average > 8-month study period) in reducing the swallowing
dysfunction, FOG, and other axial symptoms in PD patients with bilateral STN DBS and
medication refractory FOG at 130Hz stimulation, even after correcting the potential
carry-over effects between stimulation conditions.
compared to the traditional 130Hz, decreased the aspiration frequency and swallowing
difficulty, medication refractory freezing of gait (FOG), and other axial symptoms and
parkinsonism in Parkinson patients with bilateral STN DBS. The benefit of 60Hz stimulation
persisted during the 6-week study period, 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. Clarifying these
questions is essential for the application of 60Hz stimulation chronically and confidently
to treat medication refractory axial symptoms. Hence, the investigators would test the
hypothesis that the 60Hz stimulation, compared to 130Hz, would have persistent benefit over
an extended period (on average > 8-month study period) in reducing the swallowing
dysfunction, FOG, and other axial symptoms in PD patients with bilateral STN DBS and
medication refractory FOG at 130Hz stimulation, even after correcting the potential
carry-over effects between stimulation conditions.
The investigators will enroll 14 Parkinson patients with bilateral STN DBS and medication
refractory FOG at 130Hz for two visits of at least 6-month apart. The 6 patients remaining
on 60Hz stimulation after our previous study consisting of 7 patients will be assessed again
once as visit-2 at least 15-month after previous visit-1 of their last study. It will have
20 patents complete for vist-1 and at least 18 patients complete for visit-2 in this
randomized double-blind prospective crossover study with their usual medication "on" state,
with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS off). Swallowing function
on modified barium swallowing test and swallowing difficulty on questionnaire, FOG in
stand-walk-sit test and questionnaire, and other axial and motor function will be assessed
under each DBS condition. Changes in measurements between 60Hz and 130Hz at each visit and
under 60Hz between two visits will be analyzed, with swallowing function and FOG as primary,
and the rest as secondary outcomes, correcting for potential carryover effect. Changes
between other DBS conditions might also be explored in this 2-year study.
This would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG
and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and
medication refractory FOG at 130Hz stimulation, which will have significant impact on the
treatment of difficult axial symptoms of high morbidity and mortality.
refractory FOG at 130Hz for two visits of at least 6-month apart. The 6 patients remaining
on 60Hz stimulation after our previous study consisting of 7 patients will be assessed again
once as visit-2 at least 15-month after previous visit-1 of their last study. It will have
20 patents complete for vist-1 and at least 18 patients complete for visit-2 in this
randomized double-blind prospective crossover study with their usual medication "on" state,
with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS off). Swallowing function
on modified barium swallowing test and swallowing difficulty on questionnaire, FOG in
stand-walk-sit test and questionnaire, and other axial and motor function will be assessed
under each DBS condition. Changes in measurements between 60Hz and 130Hz at each visit and
under 60Hz between two visits will be analyzed, with swallowing function and FOG as primary,
and the rest as secondary outcomes, correcting for potential carryover effect. Changes
between other DBS conditions might also be explored in this 2-year study.
This would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG
and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and
medication refractory FOG at 130Hz stimulation, which will have significant impact on the
treatment of difficult axial symptoms of high morbidity and mortality.
Inclusion Criteria:
- PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual
medication "on" state.
Exclusion Criteria:
- Known history of recent aspiration pneumonia
We found this trial at
1
site
Chicago, Illinois 60637
Principal Investigator: Tao Xie, MD PhD
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