Adaptive Deep Brain Stimulation Using Subgaleal Cortical Electrodes for Movement and Sleep Symptoms in Parkinsons Disease Over 24 Hours

What this Trial Is About

Researchers are evaluating a new approach to treat Parkinsons disease by using deep brain stimulator DBS devices with electrodes placed under the scalp. The study aims to find less invasive ways to collect brain signals related to movement and sleep symptoms and to use these signals to customize adaptive DBS settings. They will compare these adaptive DBS settings to the standard continuous DBS to see which better helps manage Parkinsons symptoms. Participants will receive the Medtronic Percept RC DBS system implanted with cortical leads placed under the scalp and directional basal ganglia leads. The study includes multiple phases initial optimization of continuous DBS, followed by periods of adaptive DBS during daytime and nighttime. Nighttime testing involves randomized, blinded trials of different stimulation amplitudes over about two months, while daytime testing compares adaptive DBS and continuous DBS in randomized blocks over 40 days at home. Participants will be monitored through symptom diaries, wearable devices, and clinical assessments. Researchers will evaluate changes in bothersome movement and sleep episodes, motor function scores, and electrical energy delivered by the device. The study includes in-clinic and at-home brain recordings, sleep lab assessments, and quality of life measures. The total study duration includes long-term follow-up to support future clinical use of adaptive DBS in Parkinsons disease.

Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease