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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor.

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 data supports the effectiveness of the treatment Connectomic Guided DBS for Parkinson's Disease?

Research shows that using brain connectivity profiles from DBS electrodes can predict clinical improvements in Parkinson's patients. These profiles, whether patient-specific or based on healthy individuals, help guide DBS programming and have shown significant predictions of clinical improvement. ^{1 2 3 4 5}

Is deep brain stimulation (DBS) generally safe for humans?

Deep brain stimulation (DBS) has been used in over 70,000 patients worldwide, indicating a broad acceptance of its safety. While the research focuses on improving the precision and effectiveness of DBS, the widespread use suggests it is generally considered safe for humans. ^{1 2 4 6 7}

How is Connectomic Guided DBS treatment different from other treatments for Parkinson's Disease?

Connectomic Guided DBS is unique because it uses advanced imaging techniques to precisely target and stimulate specific brain networks, potentially improving outcomes by tailoring the treatment to individual brain connectivity patterns, unlike traditional DBS which may not account for these personalized brain connections. ^{1 2 3 4 5}

Research Team

Kyle Mitchell, MD

Principal Investigator

Duke University

Eligibility Criteria

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

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Normative vs. patient-specific brain connectivity in deep brain stimulation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Lead-DBS v2: Towards a comprehensive pipeline for deep brain stimulation imaging. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A connectomic approach for subcallosal cingulate deep brain stimulation surgery: prospective targeting in treatment-resistant depression. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

StimVision v2: Examples and Applications in Subthalamic Deep Brain Stimulation for Parkinson's Disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation induced normalization of the human functional connectome in Parkinson's disease. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Using automated electrode localization to guide stimulation management in DBS. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The national DBS brain tissue network pilot study: need for more tissue and more standardization. [2021]