Parkinson's Disease and ParkinsonismNCT05934747
Aim 3 Particle Swarm Optimization PIGD
A study testing DBS in people with Parkinson's Disease and Parkinsonism, run by University of Minnesota at 1 site in United States.
Trial summary
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism
- What is being tested?
- DBS
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 5 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Diagnosis of Parkinson's Disease
- Bilateral DBS in STN or GP
- At least 3 months after lead implantation
- Montreal Cognitive Assessment (MoCA):
MoCA=23+
OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate.
- Between 18-85 years of age
- Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care).
8.2 Exclusion Criteria:
- Inability to walk in the off-med, off-stimulation condition (even with safety harness)
- Gait impaired significantly by a condition other than PD
- Breaks or shorts in active contacts
- IPG battery nearing end of life (in patients with primary-cell IPGs)
- Females who are nursing or pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.
Read the detailed description
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.
- Conditions
- Parkinson's Disease and Parkinsonism
- Being tested
- DBS
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
Deep Brain Stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS
Difference in scores on MDS-UPDRS
Measured: 1 hour and 2 weeks after intiating stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start19 Mar 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion5 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934747
- Sponsor's protocol ID
- STUDY00019089
- Status last verified
- May 2026
- First submitted
- 28 Jun 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
- ClinicalTrials.gov ID
- NCT05934747
- Acronym / sponsor ID
- STUDY00019089
- Conditions
- Parkinson's Disease and Parkinsonism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 5 Jan 2030 (estimated)
- First posted
- 7 Jul 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.
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.
Detailed description
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DBSDeep Brain Stimulation | Device | – |
Primary outcome
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS
Time frame: 1 hour and 2 weeks after intiating stimulation
Difference in scores on MDS-UPDRS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS in people with Parkinson's Disease and Parkinsonism, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Caskey, BA (763-353-9470, caske039@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS (time frame: 1 hour and 2 weeks after intiating stimulation). 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 8 May 2026.