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

Conditions

• PD - Parkinson's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Medtronic Percept Deep Brain Stimulation (cDBS) — DEVICE
  Using the Percept pulse generator, patients receive clinically-optimized open loop stimulation to the subthalmaic nucleus.
• Medtronic Percept Deep Brain Stimulation (daytime aDBS) — DEVICE
  Using the Percept pulse generator, patients receive daytime adaptive stimulation to the subthalmaic nucleus.
• Medtronic Percept Deep Brain Stimulation (nighttime aDBS) — DEVICE
  Using the Percept pulse generator, patients receive nighttime adaptive stimulation to the subthalmaic nucleus.

Study Details

The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp. The main questions it aims to answer are: * Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms. * How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.

Key Dates

Start date

Apr 9, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2029

Completion

Nov 30, 2031

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Nighttime adaptive DBS programming
  The patient will undergo at-home blinded testing of the single power band N2/3 sleep stage aDBS (e.g 75% \& 125% conditions, levels chosen for each subject by the clinician or by the study team using data analysis) versus cDBS. Initially the patient will complete \~2 months (60 nights) of randomized, blinded, single night trials of aDBS at lower amplitude (e.g. 75%; 20 nights), aDBS at higher amplitude (e.g. 125% 20 nights) versus cDBS 100% (20 nights) to detect efficacy at the single subject level in independent N-of-1 trials. Stimulation amplitudes will be personalized and selected for tolerability and by searching for amplitudes that impact sleep physiology during the setup phase. Formal final testing will be completed in randomized, counterbalanced condition blocks. Patients will be in cDBS mode during the daytime and will perform a blinded switch to either cDBS or aDBS in the evening before going to sleep (or using the scheduling app).
• Experimental: Daytime adaptive DBS Programming
  Investigators will conduct a blinded, randomized comparison between the effects of aDBS and clinically optimized cDBS on motor signs and symptoms. Both stimulation conditions will be applied for 1 day, in blocks of 2 days that are randomized and counterbalanced for over 40 days in patients' homes. Patients will be in cDBS mode overnight and will perform a blinded switch to either cDBS or aDBS in the morning on waking (these will appear to the patient as programs C and D). Investigators will utilize patients' daily symptom diaries and wearable data. They will ask patients to complete the symptom diary (an electronic questionnaire) every night before bedtime. This focuses on the total number of hours spent with symptoms, severity, and a quality of life (QoL) score validated for daily assessment of health-related QoL (EQ-5D). Evaluated symptoms include the most bothersome and opposite symptom as well as a range of common motor symptoms including bradykinesia, dyskinesia, tremor, etc...
• Active Comparator: Open-loop continuous deep brain stimulation
  Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.

Primary Outcome Measure

Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation [ Time Frame: Baseline, aDBS testing, and during Blinded Assessment ]

Central Contacts

• Clinical Research Coordinator
  5175152739
  [email protected]
• Research Manager
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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