DBS Frequency on Swallowing Function in Parkinson's Disease

NCT ID: NCT01935011

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

Brief Summary

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The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.

Detailed Description

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This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.

The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PD DBS 60 Hz, 130 Hz or DBS off

PD DBS on 60 Hz stimulation, 130 Hz stimulation or DBS off

PD, DBS

Intervention Type OTHER

PD DBS frequency on swallowing function

Interventions

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PD, DBS

PD DBS frequency on swallowing function

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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13-0566

Identifier Type: -

Identifier Source: org_study_id

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