N/A
N=11
Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02549859 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 — 0.6; 2.9; 1.2 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Brain Stimulation (DBS) at 60 Hz (Device); Deep Brain Stimulation (DBS) at 130 Hz (Device); Deep Brain Stimulation (DBS) Off (Sham) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 |
0.6; 2.9; 1.2 | <0.05 sig |
| PRIMARY Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1 |
1.1; 3.3; 3.1 | <0.01 sig |
| PRIMARY Freezing of Gait Questionnaire at Visit 1 |
3.0; 9.3; 5.1 | <0.01 sig |
| PRIMARY Stand-Walk-Sit Freezing of Gait Spells at Visit 1 |
0.1; 3.0; 1.6 | >0.05 |
| PRIMARY Stand-Walk-Sit Time at Visit 1 |
22.1; 28.5; 23.6 | <0.05 sig |
| PRIMARY Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2 |
2.0; 3.0; 2.4 | >0.05 |
| PRIMARY Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2 |
4.8; 7.4; 5.7 | >0.05 |
| PRIMARY Freezing of Gait Questionnaire at Visit 2 |
5.9; 11.2; 7.0 | <0.01 sig |
| PRIMARY Stand-Walk-Sit Freezing of Gait Spells at Visit 2 |
2.2; 6.1; 2.5 | <0.05 sig |
| PRIMARY Stand-Walk-Sit Time at Visit 2 |
26.5; 38.4; 27.8 | >0.05 |
| SECONDARY Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1 |
22.8; 33.7; 34.4 | <0.01 sig |
| SECONDARY Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 |
3.8; 8.9; 6.9 | <0.001 sig |
| SECONDARY Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 |
11.7; 16.6; 17.1 | <0.05 sig |
| SECONDARY Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 |
4.0; 4.9; 6.0 | >0.05 |
| SECONDARY Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1 |
1.8; 1.2; 2.5 | >0.05 |
| SECONDARY Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2 |
27.1; 32.4; 31.4 | <0.05 sig |
| SECONDARY Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 |
6.8; 10.4; 8.1 | <0.05 sig |
| SECONDARY Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 |
12.8; 16.3; 15.7 | <0.05 sig |
| SECONDARY Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 |
4.3; 3.8; 4.8 | >0.05 |
| SECONDARY Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2 |
1.6; 0.2; 1.2 | >0.05 |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT02549859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.