Swallowing function with current sensory stimulation for Parkinson's disea se

JRCT ID: jRCTs062220013

Registered date:09/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's Disease
• Date of first enrollment: 01/06/2022
• Target sample size: 27
• Study type: Interventional
• Intervention(s): Using low-frequency stimulation device

Outcome(s)

• Primary Outcome: Percentage of patients with normal coughing reflection by coughing test at the end of intervention

Secondary Outcome

Percentage of patients with normal coughing reflection by coughing test after 8 weeks from the end of intervention.
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.
Percentage of patients with normal swallowing function at the end of intervention and after 8 weeks from the end of intervention.
Reduction of aspiration or laryngeal penetration analyzed by swallowing videofluorography at the end of intervention and after 8 weeks from the end of intervention.
Presence of pneumonia during the whole period.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Maruyama Hirofumi
• Source(s) of Monetary Support: Grant-in-aid for scientific research