Deep Brain Stimulation for Parkinson's Disease

Overseen By Alaa Norain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: No post-op head CT, recent DBS, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve tremor control in people with Parkinson's disease by using advanced brain imaging to guide deep brain stimulation (DBS). Researchers are testing whether targeting specific brain pathways can reduce tremors without increasing unwanted movements. The trial includes two groups: one without oral Parkinson’s medication and one with it, both undergoing different DBS settings while wearing smartwatches to track symptoms. Ideal participants have had DBS for at least three months, still experience mild tremors, and have Parkinson's disease. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future Parkinson's treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this deep brain stimulation technique is safe for Parkinson's disease patients?

In a previous study, researchers examined the safety and practicality of a new method called connectomic guided deep brain stimulation (DBS). This technique uses advanced brain imaging to more accurately target areas for treating Parkinson's disease. The study found that this method is generally safe for patients and can lead to noticeable improvements in movement. Importantly, it helps control symptoms like tremors without causing major side effects.

Research has also shown that DBS, in general, can improve common Parkinson's symptoms, such as tremors and stiffness. This supports the idea that the connectomic guided version might be a safe option. While participants should be aware of potential risks, current evidence suggests that this treatment is well-tolerated.

Participants should always consult healthcare professionals to understand what joining a trial would mean personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Connectomic Guided Deep Brain Stimulation (DBS) for Parkinson's Disease because it offers a highly personalized approach to treatment. Unlike typical DBS, which targets specific brain areas based on general anatomical landmarks, Connectomic Guided DBS uses detailed brain connectivity maps to optimize stimulation for each individual. This could lead to more effective management of symptoms like tremors and dyskinesia by precisely targeting the neural circuits involved. By tailoring the stimulation to each person's unique brain structure, this method promises to enhance the benefits of DBS and potentially reduce side effects compared to standard DBS methods.

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

Research has shown that deep brain stimulation (DBS) effectively treats Parkinson's disease. Studies indicate that targeting the subthalamic nucleus with DBS can improve patients' quality of life by reducing tremors and other symptoms. In this trial, Connectomic-guided DBS aims to enhance these effects by using advanced imaging to focus on specific brain pathways for better results. Early findings suggest that targeting the right brain areas with DBS significantly reduces tremors with fewer side effects. This method is considered safe and has shown promise in improving movement in patients with Parkinson's. ^{1 2 3 6 7}

Who Is on the Research Team?

Kyle Mitchell, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for Parkinson's disease patients who experience significant tremor and wish to improve it without worsening dyskinesias. Participants should be suitable candidates for deep brain stimulation (DBS) therapy.

Inclusion Criteria

With at least mild tremor on a pre-operatory MDS-UPDRS clinical scale as defined by at least 2 out of 4 resting tremor grading on MDS-UPDRS on at least one extremity

Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care

I have Parkinson's and have a DBS device implanted in my brain.

Exclusion Criteria

Not having a post-operative head CT with 1mm or smaller axial slices at least 1 week after initial lead implantation

Patients who received DBS less than three months prior to the start of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo deep brain stimulation (DBS) with connectomic models to optimize tremor control

8 weeks

Multiple visits for DBS parameter optimization

Data Collection

Data collected using wearables and clinical scales to assess tremor and dyskinesia

8 hours

In-person data collection sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Connectomic Guided DBS

Trial Overview The study tests if targeting specific brain pathways with DBS can better control tremors in Parkinson's patients. It compares no DBS, usual care DBS, and two optimized DBS methods based on advanced imaging models.

How Is the Trial Designed?

Group I: On oral dopaminergic medication Experimental Treatment 4 Interventions

While on oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.

Group II: No oral dopaminergic medication Experimental Treatment 4 Interventions

While off of oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. nature.com nature.com/articles/s41531-024-00639-9

Image-guided programming deep brain stimulation ... Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has been shown to improve the quality of life (QoL) of patients with Parkinson's ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06618157

Connectomic Guided DBS for Parkinson's Disease The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control ...

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30026

Prospective Connectomic‐Based Deep Brain Stimulation ... This study investigates the safety and feasibility of prospective automated connectomic DBS programming (automated connectomic programming [ACP]),

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5880678/

Connectivity Predicts Deep Brain Stimulation Outcome in ... The benefit of deep brain stimulation (DBS) for Parkinson disease (PD) may depend on connectivity between the stimulation site and other brain regions.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39431498/

Prospective Connectomic-Based Deep Brain Stimulation ... ACP appeared clinically safe and feasible. It provided reasonable motor improvement, which can be further optimized with subsequent clinical ...

6. nature.com nature.com/articles/s41467-024-48731-1

Deep brain stimulation of symptom-specific networks in ... Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.

7. sciencedirect.com sciencedirect.com/science/article/pii/S259009352500013X

A comprehensive review of deep brain stimulation for ... In this paper, we explore the history of PD treatments with a focus on DBS, as well as the developments and advancements of the technology.