Parkinson's DiseaseNCT02549859
Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
A study testing Deep Brain Stimulation (DBS) at 60 Hz and Deep Brain Stimulation (DBS) at 130 Hz in people with Parkinson's Disease, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep Brain Stimulation (DBS) at 60 Hz and Deep Brain Stimulation (DBS) at 130 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication "on" state.
Who cannot join
- Known history of recent aspiration pneumonia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago, Department of Neurology
Chicago, Illinois, 60637
About this study
Official title: 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 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.
Read the detailed description
The investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG to 130Hz stimulation and dopaminergic medications 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 once again as visit-2 after previous visit-1 of their last study. We anticipate to have 20 patents complete for visit-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 questionnaire, FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III 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 FOG refractory to 130Hz stimulation and dopaminergic medications, which will have significant impact on the treatment of difficult axial symptoms of high morbidity and mortality.
- Conditions
- Parkinson's Disease
- Being tested
- Deep Brain Stimulation (DBS) at 60 Hz, Deep Brain Stimulation (DBS) at 130 Hz, Deep Brain Stimulation (DBS) Off (Sham)
- Keywords
- DBS, Low frequency stimulation, Dysphagia, Freezing of gait
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS) at 60 HzDevice
Also called Low Frequency Stimulation (LFS)
Bilateral subthalamic nucleus deep brain stimulation at 60 Hz
Deep Brain Stimulation (DBS) at 130 HzDevice
Also called High Frequency Stimulation (HFS)
Bilateral subthalamic nucleus deep brain stimulation at 130 Hz
Deep Brain Stimulation (DBS) Off (Sham)Device
Deep Brain Stimulation (DBS) Off (Sham)
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | 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. Receives: Device: Deep Brain Stimulation (DBS) at 60 Hz; Device: Deep Brain Stimulation (DBS) at 130 Hz; Device: Deep Brain Stimulation (DBS) Off (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately following treatment for at least 30 minutes
Secondary outcomes (10)
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1
Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.
Measured: Immediately following treatment for at least 30 minutes
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.
Measured: Immediately following treatment for at least 30 minutes
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.
Measured: Immediately following treatment for at least 30 minutes
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.
Measured: Immediately following treatment for at least 30 minutes
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.
Measured: Immediately following treatment for at least 30 minutes
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2
Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.
Measured: Immediately following treatment for at least 30 minutes
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.
Measured: Immediately following treatment for at least 30 minutes
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.
Measured: Immediately following treatment for at least 30 minutes
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.
Measured: Immediately following treatment for at least 30 minutes
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.
Measured: Immediately following treatment for at least 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Tao Xie, MD PhD, Principal investigator, Department of Neurology, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549859
- Sponsor's protocol ID
- IRB 15-0539
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2015
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25540305Xie 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.
PubMed 29654112
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02549859
- Acronym / sponsor ID
- IRB 15-0539
- Conditions
- Parkinson's Disease
- Keywords
- DBS, Low frequency stimulation, Dysphagia, Freezing of gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG to 130Hz stimulation and dopaminergic medications 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 once again as visit-2 after previous visit-1 of their last study. We anticipate to have 20 patents complete for visit-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 questionnaire, FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III 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 FOG refractory to 130Hz stimulation and dopaminergic medications, which will have significant impact on the treatment of difficult axial symptoms of high morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Device: Deep Brain Stimulation (DBS) at 60 Hz, Device: Deep Brain Stimulation (DBS) at 130 Hz, Device: Deep Brain Stimulation (DBS) Off (Sham)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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication "on" state.
Key exclusion criteria (1 listed)
- Known history of recent aspiration pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (DBS) at 60 HzAlso: Low Frequency Stimulation (LFS)Bilateral subthalamic nucleus deep brain stimulation at 60 Hz | Device | Deep Brain Stimulation (DBS) |
| Deep Brain Stimulation (DBS) at 130 HzAlso: High Frequency Stimulation (HFS)Bilateral subthalamic nucleus deep brain stimulation at 130 Hz | Device | Deep Brain Stimulation (DBS) |
| Deep Brain Stimulation (DBS) Off (Sham)Deep Brain Stimulation (DBS) Off (Sham) | Device | Deep Brain Stimulation (DBS) |
Primary outcome
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
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.
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
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.
Freezing of Gait Questionnaire at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
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.
Stand-Walk-Sit Freezing of Gait Spells at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
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.
Stand-Walk-Sit Time at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
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.
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
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.
Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
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.
Freezing of Gait Questionnaire at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
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.
Stand-Walk-Sit Freezing of Gait Spells at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
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.
Stand-Walk-Sit Time at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
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.
10 secondary outcomes
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1
Time frame: Immediately following treatment for at least 30 minutes
Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2
Time frame: Immediately following treatment for at least 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25540305Xie 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.
- Results publication: PubMed 29654112Xie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Xie, MD PhD principal investigator
Department of Neurology, University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS) at 60 Hz and Deep Brain Stimulation (DBS) at 130 Hz in people with Parkinson's Disease, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1 (time frame: Immediately following treatment for at least 30 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549859, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.