RecruitingNot Applicable

Aim 3 Particle Swarm Optimization PIGD

United States30 participantsStarted 2024-03-19

Plain-language 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 structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

What they're measuring

Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS

Timeframe: 1 hour and 2 weeks after intiating stimulation

Trial details

NCT IDNCT05934747

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Johanna Caskey, BA

763-353-9470 caske039@umn.edu