Adaptive daytime DBS parameter optimization for people with Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized, intervention study examines whether adaptive deep brain stimulation can automatically adjust stimulation settings in real time for patients with the Medtronic Percept system. Participants have idiopathic Parkinson’s disease, already implanted with cDBS for at least two months, and experience residual motor fluctuations. The study uses neural signals to guide stimulation amplitude and other parameters during daily activities. Outcomes include brain recordings, stimulation testing, and clinical assessments to see if adaptive therapy improves motor control compared with baseline settings. Participants may revert to baseline cDBS settings for the clinical phase as needed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 25-75.
2. Diagnosis of idiopathic PD.
3. Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment.
4. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)).
5. Signed informed consent.
6. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
7. Patient has been on cDBS for at least two months and still experiences significant residual motor fluctuation while on cDBS. Consequently, patient is undergoing aDBS treatment currently or was recommended aDBS as part of clinical care to manage their residual motor fluctuation.
8. Has available cDBS Timeline LFP and stimulation data lasting at least 1 day.
9. To be enrolled in the clinical trial phase of the study, patient will need to consent to reverting back to their baseline cDBS settings for all required cDBS testings.

Exclusion Criteria:

1. Patient meets criteria for a psychogenic movement disorder.
2. Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
3. Any personality or mood symptoms that study personnel believe will interfere with study requirements.

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Simon Little, MBBS,PhD — University of California, San Francisco
• Study coordinator: Research Coordinator
• Email: sebastian.liu@ucsf.edu
• Phone: 5175152739

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.