Effects of Unblocking the Full Potential of Percept PC IPG

University of Toronto

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: Programming DBS using Percept PC neurostimulator's full potential

Study type

Interventional

Funder types

Other

Identifiers

NCT06127771

23-5697

Details and patient eligibility

About

Population Size and Eligible Patients: The study will enroll patients with Parkinson's disease (n=30) who had an IPG replacement from Activa PC (older generation of neurostimulator) to Medtronic PerceptTM PC (newer generation of neurostimulator) as a part of their standard-of-care. No patient will be receiving the system for research purposes only.

Study Design: This is a prospective, double-blinded, randomized, cross-over clinical investigation to further investigate the efficiency of Medtronic PerceptTM PC neurostimulator. This study involves three in clinic visits. During the first study visit, the patients' neurostimulator will be reprogrammed using all the additional features the Percept PC has to offer. At the end of the visit, the patients will be randomized between their baseline program, ((Activa PC group) and the newly defined programming settings (Percept Group). During the second visit (1-month follow-up) the effect will be clinically assessed, and a crossover of the condition will happen. The third visit (2-month follow-up) will be a follow-up visit with no programming but only clinical assessment.

Study Duration: Expected study duration is 1 year with the possibility for renewals.

Objectives and outcome measures: The goal is the study is to define whether or what the benefit is of the Percept PC neurostimulator compared to the older Activa PC neurostimulator. The primary outcome is patient-reported global impression of change (PGIC). The secondary outcome measures are clinical scales assessing symptoms of Parkinson's disease (UPDRS-III and -IV) and quality of life (PDQ-39), the active problems list and amount of medication intake.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals with idiopathic Parkinson's disease who previously underwent DBS surgery.
Individuals who had IPG replacement from Activa PC to Medtronic PerceptTM PC Neurostimulator as standard-of-care
Individuals should be able to provide their informed consent

Exclusion criteria

Cognition impairment (MoCA < 20/30)
Patients with severe PD symptoms who are unable to come to the clinic three times within three months (e.g. bedridden patients)