Parkinson DiseaseNCT06127771
Effects of Unblocking the Full Potential of Percept PC IPG
A study testing Programming DBS using Percept PC neurostimulator's full potential in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Programming DBS using Percept PC neurostimulator's full potential
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 29 Sep 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Examining the Effects of Unblocking the Full Potential of Medtronic PerceptTM PC IPG on Symptoms of Individuals with Parkinson's Disease
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.
Read more
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
- Being tested
- Programming DBS using Percept PC neurostimulator's full potential
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programming DBS using Percept PC neurostimulator's full potentialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Programming DBS using Percept PC neurostimulator's full potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
Secondary outcomes (3)
MDS-UPDRS-III
the investigators expect to see an improvement in the MDS-UPDRS-III. Part III: Motor examination: 0 to 132, with higher scores indicating greater motor impairment.
Measured: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
MDS-UPDRS-IV
the investigators expect to see an improvement in the MDS-UPDRS-IV. The score ranges from 0-24. Higher scores indicate more severe impairment.
Measured: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
The Parkinson's Disease Questionnaire (PDQ-39)
the investigators expect to see an improvement in PDQ-39. 0 to 100; being the higher the score, the worse the quality of life.
Measured: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start29 Sep 2023
- Primary completion13 Dec 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127771
- Sponsor's protocol ID
- 23-5697
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Unblocking the Full Potential of Medtronic PerceptTM PC IPG on Symptoms of Individuals with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06127771
- Acronym / sponsor ID
- 23-5697
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care programming | No intervention | –Individuals' DBS will be programmed using SOC programming parameters. |
| Percept PC programming | Experimental | Other: Programming DBS using Percept PC neurostimulator's full potentialIndividuals' DBS will be programmed using the full capacity of Percept PC IPG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programming DBS using Percept PC neurostimulator's full potentialThis 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. | Other | Percept PC programming |
Primary outcome
Patients' Global Impression of Change (PGIC) scale
Time frame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
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.
3 secondary outcomes
MDS-UPDRS-III
Time frame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
MDS-UPDRS-IV
Time frame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
The Parkinson's Disease Questionnaire (PDQ-39)
Time frame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programming DBS using Percept PC neurostimulator's full potential in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Global Impression of Change (PGIC) scale (time frame: First programming (Baseline) - Crossover programming (1 month Follow-up)- Third month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.