Simplified, scalable 24-hour adaptive deep brain stimulation for 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

Participants will be implanted with a Medtronic Percept DBS system and subgaleal (under‑scalp) electrodes to record chronic cortical signals. The recorded signals will be used to run daytime and nighttime adaptive DBS algorithms that are compared directly to each participant's clinically programmed continuous DBS. Primary outcomes include motor symptom measures, sleep metrics, and the stability and circadian variation of the recorded signals. The design aims to simplify hardware and reduce programming complexity so adaptive DBS can be scaled beyond specialist centers.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Age 25-75.
2. Diagnosis of idiopathic PD.
3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
4. Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization.
5. Normal preoperative brain MRI.
6. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA).
7. Signed informed consent.
8. Motor UPDRS-III off medication score 25 to 65 and a \>35% improvement with levodopa, predominant rigid/bradykinetic symptoms (ratio of off-medication UPDRS-III limb rigidity/bradykinesia scores to limb tremor scores of \>1.2).
9. Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias.
10. Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment.

Exclusion criteria

1. Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
2. Patient meets criteria for a psychogenic movement disorder.
3. Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
4. Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
5. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
6. Patient who requires electroconvulsive therapy, repetitive transcranial magnetic stimulation, or diathermy, implanted neurostimulators and MR-incompatible metallic implants, previous craniotomy on the side of the intended subgaleal implant, and drug or alcohol abuse.
7. Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators

Where it's running

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

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  This study tests if aMedtronic Percept adaptive DBS can dynamically adjust stimulation in people with Parkinson's who already have DBS hardware.

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• Assessing outcomes for freezing of gait in Parkinson's disease

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• Transplanting stem cells to treat Parkinson's disease

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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.