Adaptive DBS for Parkinson's Disease

(ADAPT-PD Trial)

No longer recruiting at 11 trial locations

Overseen By ADAPT-PD Trial Clinical Research Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Disqualifiers: Depression, Metallic implants, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to deep brain stimulation (DBS) called adaptive DBS (aDBS) for people with Parkinson's disease. The researchers aim to determine if this treatment is safe and effective in managing symptoms. Participants will use either a "single threshold" or "dual threshold" mode of aDBS to identify which works best. Individuals with Parkinson's disease who already use DBS therapy with specific Medtronic devices may qualify for this trial. As an unphased trial, it offers participants the chance to explore innovative treatment options that could improve their quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that your Parkinson's disease medications should be stable and expected to remain stable during the study.

What prior data suggests that adaptive DBS is safe for Parkinson's disease?

Research has shown that adaptive deep brain stimulation (aDBS) for Parkinson's disease is generally safe. Studies have found that patients tolerate aDBS well and that it remains effective over time. For example, one study reported that patients experienced overall improvement with aDBS. Another study highlighted that aDBS was a safe and manageable treatment for those with stable Parkinson's symptoms. Additionally, aDBS is a minimally invasive procedure, involving less cutting into the body, and has demonstrated high safety levels in treating brain-related diseases. These findings suggest that aDBS is a promising and safe option for managing Parkinson's disease symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Adaptive Deep Brain Stimulation (aDBS) for Parkinson's Disease because it offers a more personalized approach than traditional DBS. Unlike standard DBS, which delivers constant electrical stimulation, aDBS adjusts in real-time based on the patient's brain activity. This means it can potentially reduce side effects and improve symptom control. The trial explores two modes: the Single Threshold and Dual Threshold, each with unique ways of adapting to brain signals, offering hope for more precise and effective treatment options.

What evidence suggests that adaptive DBS is effective for Parkinson's disease?

Research has shown that adaptive deep brain stimulation (aDBS) can significantly enhance life for people with Parkinson's disease. One study found that aDBS improved movement abilities by about 34% compared to traditional DBS. In this trial, participants will join different treatment arms, including the aDBS Single Threshold and aDBS Dual Threshold modes. Patients using aDBS also experienced more "on" time, meaning their symptoms were better controlled without unwanted movements. Additionally, aDBS uses less energy, potentially extending the device's battery life. Overall, these findings suggest that aDBS could be a promising way to manage Parkinson's symptoms. ^{2 3 4 5 6}

Who Is on the Research Team?

Helen M Bronte-Stewart, MD MSE

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults with stable Parkinson's disease who respond to DBS therapy, can attend all study visits, and are not pregnant. They must use specific Medtronic DBS leads and have detectable Beta band amplitude in their brain signals. Excluded are those under 18, breastfeeding women, individuals with multiple brain implants or enrolled in other studies that could affect results.

Inclusion Criteria

My deep brain stimulation settings and Parkinson's medications will not change during the study.

I can attend all required study visits and complete the procedures.

The participant is set up to use a specific type of stimulation on at least one side.

Exclusion Criteria

I am under 18 years old.

Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team

I cannot use or tolerate wearable devices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive DBS in either Single or Dual Threshold Mode

2 months

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive DBS

Trial Overview The study tests the safety and effectiveness of adaptive Deep Brain Stimulation (aDBS) for Parkinson's patients. It involves using aDBS technology tailored to individual patient responses compared to standard settings while monitoring its impact on Parkinson's symptoms.

How Is the Trial Designed?

Group I: aDBS Single Threshold Experimental Treatment 1 Intervention

Adaptive DBS Single Threshold Mode

Group II: aDBS Dual Threshold Experimental Treatment 1 Intervention

Adaptive DBS Dual Threshold Mode

Adaptive DBS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DBS Therapy for Parkinson's Disease for:

• Adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years' duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration

Approved in European Union as DBS Therapy for Parkinson's Disease for:

• Treatment of disabling motor symptoms of recent and longer-standing Parkinson's disease, essential tremor, and epilepsy

Approved in Canada as DBS Therapy for Parkinson's Disease for:

• Treatment of disabling motor symptoms of recent and longer-standing Parkinson's disease, essential tremor, and epilepsy

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami

Published Research Related to This Trial

Deep brain stimulation (DBS) is effective for treating neurological disorders like Parkinson's disease, but traditional open-loop systems may not fully control motor fluctuations and rapid symptom changes.

Adaptive DBS (aDBS) systems, which use local field potentials (LFPs) as a feedback control variable, show promise in optimizing stimulation settings in real-time, potentially improving treatment outcomes for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive deep brain stimulation (aDBS) controlled by local field potential oscillations. Priori, A., Foffani, G., Rossi, L., et al.[2013]

Adaptive deep brain stimulation (aDBS) using on-off and proportional modulation significantly improved motor function in hemiparkinsonian rats, restoring contralateral paw use to about 45%, similar to conventional DBS.

aDBS was more energy-efficient, using approximately 40% less stimulation power than conventional DBS, suggesting it could reduce side effects while maintaining efficacy in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-Off and Proportional Closed-Loop Adaptive Deep Brain Stimulation Reduces Motor Symptoms in Freely Moving Hemiparkinsonian Rats. Evers, J., Orłowski, J., Jahns, H., et al.[2023]

Closed-loop adaptive deep brain stimulation (aDBS) targeting the subthalamic nucleus (STN) effectively suppresses abnormal beta oscillations in Parkinson's disease, leading to improved motor function.

aDBS requires significantly less stimulation current compared to conventional deep brain stimulation (cDBS), potentially reducing side effects while maintaining therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient suppression of parkinsonian beta oscillations in a closed-loop model of deep brain stimulation with amplitude modulation. Bahadori-Jahromi, F., Salehi, S., Madadi Asl, M., et al.[2023]

Adaptive deep brain stimulation (aDBS) offers a promising advancement over conventional deep brain stimulation (cDBS) for treating Parkinson's Disease by allowing real-time adjustments to stimulation parameters based on the patient's clinical state.

The effectiveness of aDBS heavily relies on the selection of control variables and algorithms, which presents challenges in system design and implementation, highlighting the need for careful consideration in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adaptive deep brain stimulation challenge. Arlotti, M., Rosa, M., Marceglia, S., et al.[2018]

Adaptive deep brain stimulation (aDBS) is a promising advancement in treating essential tremor and Parkinson's disease, as it adjusts stimulation based on real-time feedback from brain activity or tremor data.

Current studies on aDBS show proof-of-principle but are limited by their short duration; further research is needed to implement aDBS effectively in long-term treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Deep Brain Stimulation for Movement Disorders: The Long Road to Clinical Therapy. Meidahl, AC., Tinkhauser, G., Herz, DM., et al.[2022]

Adaptive deep brain stimulation (aDBS) can significantly reduce side effects and prolong pacemaker battery life in patients with advanced Parkinson's disease by using closed-loop feedback and spatial adaptation techniques.

aDBS offers improved efficacy through automatic adjustments to stimulation parameters, allowing for better management of the patient's condition over time, which is a major advancement over traditional continuous stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward adaptive deep brain stimulation in Parkinson's disease: a review. Mohammed, A., Bayford, R., Demosthenous, A.[2019]

Adaptive deep brain stimulation (aDBS) shows promise in improving Parkinson's disease treatment by adjusting stimulation in real-time based on the patient's brain activity, specifically targeting beta amplitude fluctuations.

In early trials, aDBS demonstrated reduced power consumption and improved motor function scores compared to traditional deep brain stimulation, suggesting it could be a more efficient and effective long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling Parkinson's disease with adaptive deep brain stimulation. Little, S., Pogosyan, A., Neal, S., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

2. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36471098/

Adaptive deep brain stimulation for Parkinson's disease Results: Quantitative analysis showed that aDBS, with a reduction of TEED (55% of that of cDBS), significantly improved motor functions (33.9%, ...

4. apdaparkinson.org apdaparkinson.org/article/adaptive-deep-brain-stimulation-dbs/

Adaptive DBS: A New Era in Parkinson's Disease Treatment Results showed that patients using adaptive DBS experienced significant improvements in “on” time without troublesome dyskinesias, needed lower ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357172/

Closed-Loop Adaptive Deep Brain Stimulation in ... Concerning PD, multiple clinical studies have demonstrated that DBS was more effective than best medical therapy for moderate-to-severe PD [9] ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40982287/

Long-Term Personalized Adaptive Deep Brain Stimulation ... Importance: Adaptive deep brain stimulation (aDBS) automatically adjusts stimulation amplitude in response to changes in relevant neural ...