Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy

Parkinson's Disease Clinical Trial

Official title:

Ambulatory Movement Registration in Patients With Deep Brain Stimulation and Continuous Intraduodenal Levodopa Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701803
• Other study ID #: HospitalDHU
• Status: Completed
• Start date: October 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2019
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device. In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing it with written patient diaries.

Description:

In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ logger (PKG) device which is a movement and acceleration measuring device.

A measurement is done before and after the implantation of selected therapy. PKG will measure automatically in every two minutes the movement of selected limb (usually the more affected upper extremity) for six days. At the same time a patient will keep a written diary of his/her Parkinsonian symptoms. Diary and collected PKG data will be compared. PKG will also remind with vibration the patient of the time drug administration and the patient can confirm this with pressing a button on PKG. The collected data will be transmitted to a computer and analyzed mathematically to produce a visual graph of daily movements. The aim is to evaluate PKG's usability in measuring Parkinsonian symptoms and in evaluation the outcome of DBS and levodopa therapy. Main parameters in evaluation are bradykinesia score and dyskinesia score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient with diagnosed Parkinson's disease

• Parkinson's disease is in advanced state (defined by the treating physician)

• A good response with over 30 % improvement of scores in Unified Parkinson's disease rating scale part III in pre-DBS evaluation

Exclusion Criteria:

• Age older than 70 years (this is a clinical exclusion criteria for DBS treatment)

• No history of psychosis or depression (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)

• No diagnosed dementia (this is a clinical exclusion criteria for DBS and intraduodenal levodopa therapy)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Parkinson's KinetiGraph™ logger
Logger is recording device which records the movement and acceleration of upper extremity

Locations

Country	Name	City	State
Finland	HUH Meilahti Hospital, department of neurology	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bradykinesia score	BKS is summary of bradykinesia presented in PKG recordings, BKS, 0 - 50	6 months
Secondary	Dyskinesia score	DKS summary of dyskinesia presented in PKG recordings, DKS, 0 - 50	6 months