NCT07798271Toboroz
Optimizing Adaptive DBS for Parkinson's Disease
Optimizing Adaptive Deep Brain Stimulation for Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 1.
Rövid összefoglaló (regiszter, angolul)
Parkinson's disease (PD) affects more than 10 million people worldwide and causes progressive motor symptoms such as slowness, stiffness and tremor. For patients whose symptoms are no longer adequately controlled with medication, deep brain stimulation (DBS) can substantially improve motor function. More recently, adaptive DBS (aDBS) has become available. Unlike conventional DBS, which delivers continuous stimulation, aDBS automatically adjusts stimulation in response to brain activity recorded by the implanted device. Current clinical aDBS programming is based primarily on brief recordings obtained during clinic visits. However, Parkinson's symptoms and the underlying brain signals change throughout the day in response to medication, daily activities and other factors. As a result, recordings collected during a single clinic visit may not fully capture the neural activity that best reflects a patient's symptoms in everyday life. The purpose of this study is to determine whether incorporating long-term brain recordings collected during daily life improves adaptive DBS programming and clinical outcomes. Participants will first undergo in-clinic testing to identify brain signals associated with their symptoms. Brain activity and symptoms will then be monitored during everyday life using the sensing capabilities of the implanted DBS device. Participants with suitable brain signals will enter a randomized, blinded crossover study comparing three stimulation approaches: conventional continuous DBS, adaptive DBS programmed using the current clinic-based approach and adaptive DBS programmed using both clinic and at-home recordings. The study will compare the effects of these approaches on motor fluctuations and quality of life. It will also determine how frequently different brain signals occur in people with Parkinson's disease and how well they reflect motor symptoms, providing information that may improve future adaptive DBS therapies.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 35 (tervezett)
- Első benyújtás
- 2026. aug. 6.
- Kezdés
- 2026. máj. 8.
- Elsődleges befejezés
- 2032. júl. 1.
- Fő szponzor
- University of California, Davis
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07798271
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 35
- 2026. máj. 8. és az elsődleges befejezés (2032. júl. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior brain surgery other than STN DBS
Más betegség
- Clinically significant cognitive impairment or dementia, defined as MoCA \< 24 or equivalent, or lacking capacity to provide informed consent
- Active psychiatric illness that could compromise safety or participation (e.g., uncontrolled depression, psychosis, severe anxiety disorder)
- History of suicidality or suicide attempt within the past year
- Clinically unstable medical conditions (e.g., uncontrolled hypertension, advanced cardiac or pulmonary disease) that would increase study risk
Egyéb
- Atypical or secondary parkinsonism (e.g., multiple system atrophy, progressive supranuclear palsy, vascular parkinsonism)
- Current substance abuse or dependence
- Ongoing participation in another interventional trial that could confound outcomes
- Pregnancy or plans to become pregnant during the study period
- Inability or unwillingness to comply with study procedures (e.g., at-home monitoring, study visits, data collection)
Kiket keres a vizsgálat
- Subjects will be 18 and over
- Clinical diagnosis of idiopathic Parkinson's disease (PD), consistent with MDS diagnostic criteria
- Motor fluctuations in response to medication
- Bilateral subthalamic nucleus (STN) DBS using a commercial sensing-enabled device
- Stable cDBS settings for ≥3 months prior to enrollment
- Stable antiparkinsonian medication regimen for ≥4 weeks prior to enrollment
- Capacity to provide informed consent
- Ability and willingness to complete study visits and at-home monitoring
- For Part 2: Presence of an adequate STN neural signal (e.g., stable LFP feature suitable for biomarker extraction) during screening
- Ability to speak and understand English sufficiently to provide informed consent and complete study procedures and assessments without an interpreter.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UC Davis Center for Neuroscience Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Davis | Egyesült Államok | Toboroz |
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