Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions

Summary

Participation Requirements

Description

A patients participation in the study will last for up to 4 years and will include up to nine visits: Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit) Pre-surgery / explantation surgery / post-surgery (3 visits) Safety (4 visits) DAT-PET (Dopamine Transporter - Positron Emission Tomogra...

A patients participation in the study will last for up to 4 years and will include up to nine visits: Screening (1 visit, same as HP-CD-CL-2003 End-of-Study visit) Pre-surgery / explantation surgery / post-surgery (3 visits) Safety (4 visits) DAT-PET (Dopamine Transporter - Positron Emission Tomography) examination (1 visit) End-of-study visit (1 visit) Study examinations and assessments: Physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (BMI), neurological exam ECG (electrocardiography) and blood and urine tests Pregnancy tests for women of childbearing age Completion of a patient diary to record mobility and time asleep Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type movement recording device Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health. Magnetic resonance imaging (MRI) Positron emission tomography scans (PET) Skin condition over any remaining implanted subcutaneous portion of the device. Skin healing after port / device removal. For more information: https://treater.eu/clinical-study/

Tracking Information