DBS Frequency on Swallowing Function in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Effects of the Stimulation Frequency of STN DBS on Swallowing Function in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935011
• Other study ID #: 13-0566
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: April 27, 2015
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.

Exclusion Criteria:

• Patients who do not meet the inclusion criteria

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• PD, DBS
PD DBS frequency on swallowing function

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome would be the OPMS swallowing function scores	Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the oropharyngeal motility study (OPMS) of the oral, pharyngeal and esophageal phase function will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks. ANOVA will be used for group comparison of the scores. A regression model will be further used to assess the predicting value (s) of the other scores and demographics for the swallowing function.	One year	No
Secondary	The secondary outcome would be the swallowing questionnaire score	Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the swallowing questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.	One year	No
Secondary	The secondary outcome would also be the unified PD rating scale	Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the unified PD rating scale will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.	One year	No
Secondary	The secondary outcome would be the FOG questionnaire score	Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the FOG questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.	One year	No
Secondary	The secondary outcome would be the standing-walking-sitting test score	Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the standing-walking-sitting test will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.	One year	No