Swallowing function with current sensory stimulation for Parkinson's disease

Phase 2

• Conditions: Parkinson's Disease; Parkinson's disease, neurodegenerative disease; 20052621 (ICD10)

• Registration Number: JPRN-jRCTs062220013
• Lead Sponsor: Maruyama Hirofumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Diagnosed as Parkinson's disease
Hoehn Yahr stage is from 2 to 4
No change of levodopa during 1 month before the
inclusion.
Capable of visiting hospital twice a week

Exclusion Criteria

Using pacemaker or implantable cardioverter defi
brillator
Patients who is pregnant or will be pregnant
Past history of head and neck cancer or surgery
Active pneumonia
Receiving rehabilitation of swallowing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with normal coughing reflection by coughing test at the end of intervention

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with normal coughing reflection by coughing test after 8 weeks from the end of intervention.<br>Increment of provocative rate during 30 seconds after starting the coughing test at the end of intervention and after 8 weeks from the end of intervention.<br>Percentage of patients with normal swallowing function at the end of intervention and after 8 weeks from the end of intervention.<br>Reduction of aspiration or laryngeal penetration analyzed by swallowing videofluorography at the end of intervention and after 8 weeks from the end of intervention.<br>Presence of pneumonia during the whole period.