Salivary secretion in Parkinson's Disease patients with and without deep brain stimulatio
- Conditions
- G20R68.2Parkinson diseaseDry mouth, unspecified
- Registration Number
- DRKS00013232
- Lead Sponsor
- niklinik KölnAbteilung für Zahnerhaltung und Parodontologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
• Patients with Parkinson's disease: after DBS (Deep Brain Stimulation) at least 3 months ago (Arm 1) or without DBS (Arm 2)
• written informed consent
• minimum 18 years old
• actual or planned pregnancy during the study
• actual or anamnestic radiation or chemotherapy in the head/neck region
• actual or anamnestic parotid tumor
• actual or anamnestic surgery in the head/neck region
• Sjögren-Syndrome
• daily intake of symptom-relieving products against xerostomia, besides frequent water intake
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Deep Brain Stimulation on salivation rates<br><br>Therefore among Parkinson's disease patients with and without deep brain Stimulation in the Medication- OFF Status, there is Salivation amount measurement. Salivation rates is done by collecting all produced saliva for five minutes, afterwards saliva amount is measured. Finally the Stimulator is turned on again.
- Secondary Outcome Measures
Name Time Method Effect of Dopamine on salivation rates, therefore, in the medication-OFF Status of Parkinson's disease patients without Deep Brain Stimulation, patients receive a standardized L-Dopa amount (200 mg), before and directly after salivation amounts are measured according to the primary endpoint. Masticatory function: participants chew 20 chewing cycles on two differently coloured chewing gums. Afterwards the degree of intermixing is documented by a specialized Software.