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Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS

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ClinicalTrials.gov Identifier: NCT02549859
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: DBS Phase 2 Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DBS 60Hz
Patients will have a randomized double-blind prospective crossover study with usual medication "on" state under 3 different DBS stimulation frequency condition (60Hz vs 130Hz vs DBS off). Aspiration frequency 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 of 8 months apart on average 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.
Device: DBS
Patients will have a randomized double-blind prospective crossover study with usual medication "on" state under 3 different DBS stimulation frequency condition (60Hz vs 130Hz vs DBS off). Aspiration frequency 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 of 8 months apart on average 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.
Other Name: DBS 60Hz, DBS 130Hz, DBS off state
Experimental: DBS 130Hz
As above
Device: DBS
Patients will have a randomized double-blind prospective crossover study with usual medication "on" state under 3 different DBS stimulation frequency condition (60Hz vs 130Hz vs DBS off). Aspiration frequency 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 of 8 months apart on average 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.
Other Name: DBS 60Hz, DBS 130Hz, DBS off state
Experimental: DBS off
As above
Device: DBS
Patients will have a randomized double-blind prospective crossover study with usual medication "on" state under 3 different DBS stimulation frequency condition (60Hz vs 130Hz vs DBS off). Aspiration frequency 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 of 8 months apart on average 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.
Other Name: DBS 60Hz, DBS 130Hz, DBS off state



Primary Outcome Measures :
  1. Long-term effect of 60Hz compared to 130Hz on swallowing function (objective modified barium swallowing & swallowing questionnaire) & effect on freezing of gait (objective stand-walk-sit study & questionnaire) in PD patients with bilateral STN DBS [ Time Frame: At least 6-month (on average 8-month) duration will be followed after the patient is on 60Hz stimulation ]

Secondary Outcome Measures :
  1. Long-term effect of 60Hz compared to 130Hz stimulation on the overall parkinsonian motor symptoms (UPDRS-III score) in PD patients with bilateral STN DBS [ Time Frame: At least 6-month (on average 8-month) duration will be followed after the patient is on 60Hz stimulation ]
  2. Long-term effect of 60Hz compared to 130Hz stimulation on the overall axial symptoms (UPDRS-III axial subscore) in PD patients with bilateral STN DBS [ Time Frame: At least 6-month (on average 8-month) duration will be followed after the patient is on 60Hz stimulation ]
  3. Long-term effect of 60Hz compared to 130Hz stimulation on the overall tremor symptoms (UPDRS-III tremor subscore) in PD patients with bilateral STN DBS [ Time Frame: At least 6-month (on average 8-month) duration will be followed after the patient is on 60Hz stimulation ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549859


Locations
United States, Illinois
University of Chicago, Department of Neurology
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Tao Xie, MD PhD Department of Neurology, University of Chicago

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02549859     History of Changes
Other Study ID Numbers: IRB 15-0539
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by University of Chicago:
DBS
Low frequency stimulation
Dysphagia
Freezing of gait

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases