DBS Frequency on Swallowing Function in Parkinson's Disease

NCT01935011 | Completed

• 1 other identifier: 13-0566
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• The secondary outcome would be the swallowing questionnaire score

  One year

• The secondary outcome would also be the unified PD rating scale

  One year

• The secondary outcome would be the FOG questionnaire score

  One year

• The secondary outcome would be the standing-walking-sitting test score

  One year

Study Arms (1)

PD DBS 60 Hz, 130 Hz or DBS off

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

Other: PD, DBS

Interventions

PD, DBS OTHER

PD DBS frequency on swallowing function

PD DBS 60 Hz, 130 Hz or DBS off

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Tao Xie, MD PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)