Using advanced imaging to improve deep brain stimulation for Parkinson's disease tremors
Connectomic Guided Deep Brain Stimulation (DBS) for Parkinson's Disease
This study is testing if using advanced brain imaging can help improve deep brain stimulation for people with Parkinson's disease to better control their tremors and reduce side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06618157 on ClinicalTrials.gov |
What this trial studies
This research aims to enhance deep brain stimulation (DBS) for patients with Parkinson's disease by utilizing advanced connectomic imaging models to identify specific axonal pathway targets. The focus is on optimizing stimulation parameters to improve tremor control while minimizing side effects like dyskinesias. By understanding the connectivity of brain networks, the study seeks to provide a more precise and effective treatment approach for patients suffering from significant tremors. The study will compare different DBS techniques, including cerebellothalamic and pallidothalamic optimized stimulation, against usual care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with Parkinson's disease who have been implanted with bilateral subthalamic nucleus DBS and exhibit at least mild tremor.
Not a fit: Patients who have not had DBS for at least three months or those without significant tremor may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved tremor control and reduced side effects for patients with Parkinson's disease.
How similar studies have performed: While studies have explored structural connectivity in Parkinson's disease, this specific approach using connectomic models for optimizing DBS parameters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Diagnosed with Parkinson's disease and has previously been implanted with bilateral subthalamic nucleus deep brain stimulation (DBS) * Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care * 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 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
Where this trial is running
Durham, North Carolina
- Duke Health Center at Morreene Road — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kyle Mitchell, MD — Duke University
- Study coordinator: Talita D Aguiar Rosa, MD
- Email: talita.daguiarrosa@duke.edu
- Phone: 415-670-0665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.