Deep Brain Stimulation for Parkinson's Disease
(Subgaleal aDBS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for Parkinson's disease using a device implanted in the brain to address movement and sleep issues. The researchers aim to determine if brain signals can guide device adjustments for better symptom control compared to the usual method. Participants will try different device settings to compare their effects on daily symptoms. Suitable candidates have Parkinson's disease with persistent symptoms despite medication and experience movement or sleep problems. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance future treatment options.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should have motor fluctuations despite optimized medical therapy, which suggests you may continue your current medications.
What prior data suggests that this deep brain stimulation device is safe for treating Parkinson's disease?
Research has shown that adaptive deep brain stimulation (aDBS) for Parkinson's disease is generally safe and well-tolerated. Studies have found that long-term use of aDBS is safe and effective for individuals who have previously used continuous deep brain stimulation (DBS). Most patients do not experience serious side effects.
However, like any medical procedure, some risks exist. These can include surgical complications and infections. Additionally, the device might not always function as expected, and in some cases, symptoms might worsen.
Overall, while some risks are present, research supports aDBS as a safe option for many people with Parkinson's disease.12345Why are researchers excited about this trial?
Researchers are excited about the Deep Brain Stimulation (DBS) techniques being tested for Parkinson's Disease because they offer a personalized approach to managing symptoms. Unlike current standard treatments like medication or traditional DBS that provide consistent, unvarying stimulation, these new methods adapt to the patient's needs. The nighttime adaptive DBS programming adjusts stimulation levels based on sleep stages, potentially improving sleep quality. Meanwhile, the daytime adaptive DBS programming uses wearable technology and patient diaries to tailor stimulation to daily symptoms, aiming for better control of motor issues such as tremors and stiffness. This level of customization could lead to more effective and comfortable management of Parkinson's symptoms.
What evidence suggests that this trial's treatments could be effective for Parkinson's disease?
This trial will compare different programming approaches for deep brain stimulation (DBS) in treating Parkinson's disease. Research has shown that adaptive deep brain stimulation (aDBS), one of the approaches tested in this trial, can help treat Parkinson's disease. Studies have found that long-term use of aDBS is safe, manageable, and improves symptoms in people whose Parkinson's disease was previously stable. For nighttime use, aDBS has led to noticeable improvements in well-being and movement. During the day, aDBS has been linked to better control of symptoms like tremors, stiffness, and slow movements. Overall, aDBS may enhance quality of life by effectively managing symptoms and possibly reducing the need for medication.26789
Who Is on the Research Team?
Simon Little
Principal Investigator
University of California, San Francisco
Philip Starr
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people aged 25-75 with Parkinson's Disease who haven't found relief through oral medications. They should have a normal brain MRI, no serious cognitive issues (MoCA score ≥24), and experience motor fluctuations despite medication. Candidates must consent to the study and be able to attend follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Setup
Participants are implanted with deep brain stimulator devices and electrodes placed under the scalp. Initial setup and optimization of continuous DBS settings.
Daytime Adaptive DBS Programming
Blinded, randomized comparison between adaptive DBS and clinically optimized continuous DBS on motor signs and symptoms over 40 days.
Nighttime Adaptive DBS Programming
At-home blinded testing of adaptive DBS during sleep, with randomized, blinded, single night trials over approximately 2 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic Percept Deep Brain Stimulation
Trial Overview
Researchers are testing a new adaptive deep brain stimulation (DBS) method using Medtronic Percept devices implanted under the scalp. The goal is to tailor DBS settings based on brain signals related to movement and sleep symptoms, comparing these settings with standard continuous DBS treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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).
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...
Participants with Parkinson's disease implanted with Percept and receiving open-loop deep brain stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
1.
medtronic.com
medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/dbs-technologies/brainsense-technology.htmlBrainSense™ Technology
Medtronic DBS therapy is approved for five indications: Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder (OCD), and epilepsy.
Long-Term Personalized Adaptive Deep Brain Stimulation ...
Meaning Long-term aDBS provided tolerable, effective, and safe therapy in persons with Parkinson disease whose symptoms were previously stable ...
Chronic adaptive deep brain stimulation for Parkinson's disease
Within-subject analysis showed a significant improvement in overall well-being and general movement in three of eight patients. Six of eight ...
4.
medtronic.com
medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-parkinsons-disease.htmlDeep Brain Stimulation for Parkinson's Disease
DBS may help control the movement symptoms of Parkinson's disease: tremor, slowed movement, and stiffness.
Adaptive DBS: A New Era in Parkinson's Disease Treatment
The therapy can dramatically improve tremors, stiffness, and slow movements – and allow for reductions in medication dosage. However, ...
P960009/S478 Summary of Safety and Effectiveness (SSED)
The current supplement (S478) introduces a new optional programming feature called adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing ...
BrainSense™ Adaptive DBS (aDBS)
The ADAPT-PD clinical trial's intent was to determine safety and effectiveness of the adaptive feature within a clinical workflow and with the ...
BrainSense™ Adaptive Deep Brain Stimulation (aDBS)
As such, several small safety and feasibility studies have explored the use of aDBS to address a number of cardinal motor symptoms of PD.
9.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/trial-adaptive-dbs-is-tolerable-effective-and-safeTrial: Adaptive DBS Is Tolerable, Effective and Safe - Consult QD
The study found that long-term aDBS was safe, effective and tolerable for the participants, who previously were stable on continuous DBS and ...
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