Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
1 other identifier
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
October 1, 2020
CompletedOctober 29, 2020
October 1, 2020
1.8 years
August 31, 2015
May 28, 2020
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1
A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.
Immediately following treatment for at least 30 minutes
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1
The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.
Immediately following treatment for at least 30 minutes
Freezing of Gait Questionnaire at Visit 1
The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.
Immediately following treatment for at least 30 minutes
Stand-Walk-Sit Freezing of Gait Spells at Visit 1
The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.
Immediately following treatment for at least 30 minutes
Stand-Walk-Sit Time at Visit 1
Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.
Immediately following treatment for at least 30 minutes
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2
A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.
Immediately following treatment for at least 30 minutes
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2
The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.
Immediately following treatment for at least 30 minutes
Freezing of Gait Questionnaire at Visit 2
The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.
Immediately following treatment for at least 30 minutes
Stand-Walk-Sit Freezing of Gait Spells at Visit 2
The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.
Immediately following treatment for at least 30 minutes
Stand-Walk-Sit Time at Visit 2
Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.
Immediately following treatment for at least 30 minutes
Secondary Outcomes (10)
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1
Immediately following treatment for at least 30 minutes
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Immediately following treatment for at least 30 minutes
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Immediately following treatment for at least 30 minutes
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Immediately following treatment for at least 30 minutes
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Immediately following treatment for at least 30 minutes
- +5 more secondary outcomes
Study Arms (1)
Deep Brain Stimulation (DBS)
EXPERIMENTALAll 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.
Interventions
Bilateral subthalamic nucleus deep brain stimulation at 60 Hz
Bilateral subthalamic nucleus deep brain stimulation at 130 Hz
Deep Brain Stimulation (DBS) Off (Sham)
Eligibility Criteria
You may qualify if:
- PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication "on" state.
You may not qualify if:
- Known history of recent aspiration pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago, Department of Neurology
Chicago, Illinois, 60637, United States
Related Publications (2)
Xie T, Vigil J, MacCracken E, Gasparaitis A, Young J, Kang W, Bernard J, Warnke P, Kang UJ. Low-frequency stimulation of STN-DBS reduces aspiration and freezing of gait in patients with PD. Neurology. 2015 Jan 27;84(4):415-20. doi: 10.1212/WNL.0000000000001184. Epub 2014 Dec 24.
PMID: 25540305RESULTXie T, Bloom L, Padmanaban M, Bertacchi B, Kang W, MacCracken E, Dachman A, Vigil J, Satzer D, Zadikoff C, Markopoulou K, Warnke P, Kang UJ. Long-term effect of low frequency stimulation of STN on dysphagia, freezing of gait and other motor symptoms in PD. J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):989-994. doi: 10.1136/jnnp-2018-318060. Epub 2018 Apr 13.
PMID: 29654112RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
It is only tested on PD patients with FOG refractory to the 130Hz of bilateral STN DBS at usual medication "on" state, with limited participants.
Results Point of Contact
- Title
- Ms. Lani Leong, Research Coordinator
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Tao Xie, MD PhD
Department of Neurology, University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 15, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
October 29, 2020
Results First Posted
October 1, 2020
Record last verified: 2020-10