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

NCT ID: NCT02701803

Last Updated: 2019-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Parkinson's KinetiGraph™ logger

Logger is recording device which records the movement and acceleration of upper extremity

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role lead

Responsible Party

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Maija Koivu

Specialising physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eero Pekkonen, M.D., Ph.D.

Role: STUDY_DIRECTOR

HUH, Meilahti Hospital, department of neurology

Locations

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HUH Meilahti Hospital, department of neurology

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HospitalDHU

Identifier Type: -

Identifier Source: org_study_id

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