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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Tidig fas 1
Kontakter och platser
Studiekontakt
- Namn: Johanna Caskey, BA
- Telefonnummer: 763-353-9470
- E-post: caske039@umn.edu
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- Rekrytering
- University of Minnesota
-
Huvudutredare:
- Scott Cooper, MD, PhD
-
Kontakt:
- Johanna Caskey, BA
- Telefonnummer: 763-353-9470
- E-post: caske039@umn.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gait Test
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Scott Cooper, MD, PhD, University of Minnesota
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NEUR-2026-34549
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .