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

NCT ID: NCT02549859

Last Updated: 2020-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation (DBS)

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.

Group Type EXPERIMENTAL

Deep Brain Stimulation (DBS) at 60 Hz

Intervention Type DEVICE

Bilateral subthalamic nucleus deep brain stimulation at 60 Hz

Deep Brain Stimulation (DBS) at 130 Hz

Intervention Type DEVICE

Bilateral subthalamic nucleus deep brain stimulation at 130 Hz

Deep Brain Stimulation (DBS) Off (Sham)

Intervention Type DEVICE

Deep Brain Stimulation (DBS) Off (Sham)

Interventions

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Deep Brain Stimulation (DBS) at 60 Hz

Bilateral subthalamic nucleus deep brain stimulation at 60 Hz

Intervention Type DEVICE

Deep Brain Stimulation (DBS) at 130 Hz

Bilateral subthalamic nucleus deep brain stimulation at 130 Hz

Intervention Type DEVICE

Deep Brain Stimulation (DBS) Off (Sham)

Deep Brain Stimulation (DBS) Off (Sham)

Intervention Type DEVICE

Other Intervention Names

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Low Frequency Stimulation (LFS) High Frequency Stimulation (HFS)

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Xie, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Chicago

Locations

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University of Chicago, Department of Neurology

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25540305 (View on PubMed)

Xie 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.

Reference Type RESULT
PMID: 29654112 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB 15-0539

Identifier Type: -

Identifier Source: org_study_id