Bayesian Optimization of DBS for Gait (BOG DBS)
This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients will be enrolled who have DBS of the subthalamic nucleus (STN) or globus pallidus (GP) in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. We will apply Bayesian optimization to derive DBS settings which maximally lengthen step length relative to the OFF DBS state.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on the output of the Bayesian optimization algorithm. Test settings will be evaluated by a brief period of walking on a treadmill which captures measurements of step length. The resulting step length will be provided to the algorithm to inform the next recommended test setting. This will be repeated approximately 30 times to reach putatively optimal DBS settings.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Johanna Caskey, BA
- Telefonnummer: 763-353-9470
- E-mail: caske039@umn.edu
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Rekruttering
- University of Minnesota
-
Ledende efterforsker:
- Scott Cooper, MD, PhD
-
Kontakt:
- Johanna Caskey, BA
- Telefonnummer: 763-353-9470
- E-mail: caske039@umn.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of Parkinson's Disease
- DBS in STN or GP (bilateral or unilateral)
- At least 3 months after lead implantation
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, as determined by the PI
- Breaks or shorts in active contacts
- IPG battery nearing end of life (in patients with primary-cell IPGs)
- Females who are nursing or pregnant
- Diminished capacity to consent (concluded via UBACC)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: All participants
All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD. |
DBS within FDA-approved limits and labeling for symptoms of PD |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait Test
Tidsramme: This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.
|
Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe-off events. These events, and the treadmill speed, are used to compute step lengths. |
This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Scott Cooper, MD, PhD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEUR-2026-34549
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .