Effects of Unblocking the Full Potential of Percept PC IPG

NCT06127771 | Completed

• 1 other identifier: 23-5697
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Patients' Global Impression of Change (PGIC) scale

  the investigators expect to see an improvement of PGIC due to a decrease in (the severity of) active problems. The PGIC scale ranges from 1 to 7, with 1 indicating no change and 7 signifying a substantial improvement.

  First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up

Secondary Outcomes (3)

• MDS-UPDRS-III

  First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up

• MDS-UPDRS-IV

  First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up

• The Parkinson's Disease Questionnaire (PDQ-39)

  First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up

Study Arms (2)

Standard of Care programming

NO INTERVENTION

Individuals' DBS will be programmed using SOC programming parameters.

Percept PC programming

EXPERIMENTAL

Individuals' DBS will be programmed using the full capacity of Percept PC IPG.

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

Interventions

Programming DBS using Percept PC neurostimulator's full potential OTHER

This study aims to enroll patients who previously had Activa PC neurostimulator and underwent a battery change to Medtronic PerceptTM PC as standard-of-care. However, in this study, the investigators intent to fully utilize the programming potential of Medtronic PerceptTM PC to optimize treatment outcome.

Percept PC programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Alfonso Fasano, MD, PhD, FAAN, Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: September 29, 2023
• Primary Completion: December 13, 2023
• Study Completion: November 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)