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

ConditionPD - Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 25-75.

Diagnosis of idiopathic PD.

Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).

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.

Disqualifiers

Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.

Patient meets criteria for a psychogenic movement disorder.

Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.

Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Nighttime adaptive DBS programmingExperimental treatment 2 interventions
Group B: Daytime adaptive DBS ProgrammingExperimental treatment 2 interventions
Group C: Open-loop continuous deep brain stimulationActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in number of bothersome movement and/or sleep episodes on adaptive deep brain stimulation compared to open-loop deep brain stimulation

Troublesome movement and/or sleep episodes will be detected using validated home wearable devices along with participant self-reporting.

Time frame
Baseline, aDBS testing, and during Blinded Assessment

Secondary outcomes

1

Change in MDS-UPDRS III scores

Change in Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) III score. The scale consists of 18 items that are each scored 0 to 3, making the total score out of 72 points, with higher scores indicating higher impairment.

Time frame
Baseline, aDBS testing, and Blinded Assessment
2

Change in Total Electrical Energy Delivered (TEED)

Change in TEED calculated using voltage, frequency, pulse width, and impedence values from participant pulse generators, with adaptive compared to open-loop deep brain stimulation (DBS). TEED is measured in microjoules.

Time frame
Baseline, aDBS testing, and Blinded Assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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