An interventional study of Cerebellothalamic optimized deep brain stimulation and Pallidothalamic optimized deep brain stimulation in Parkinson Disease, Tremor and Dyskinesias, sponsored by Duke University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
Patients with Parkinson's disease (PD) can suffer from significant disability due to tremors, rigidity, bradykinesia, or motor fluctuations, in addition to non-motor symptoms of the disease. Deep brain stimulation (DBS) is the main surgical approach approved by the US Food and Drug Administration (FDA) for the treatment of medication-refractory PD. Despite recent advances, the selection of DBS parameters is based on trial-and-error experimentation by specialists over the course of months. Better understanding of the optimal network targets for symptomatic control would allow for therapy improvement and simplify the DBS programming process, increase efficiency, and possibly increase access to care.
Most studies of structural connectivity in PD have focused on the analysis of the subthalamic nucleus (STN). Previous studies analyzing structural connectivity of STN DBS have shown that specific motor symptoms benefit from the activation of different networks. Several tracts such as the cerebellothalamic tract (CBT), pallidothalamic (PT) and corticospinal tract (CST) course through the STN and might be relevant for DBS targeting. For patients with essential tremor, stimulation of the CBT might provide better tremor control, but studies in PD are lacking.
The investigators will use connectomic models to better understand the mechanistic qualities of axonal pathways in the STN in Parkinson's disease and address the need for phenotype driven stimulation in PD. Estimating targeted axonal pathways by using connectomic models may guide personalized decision-making and targeting of DBS. It has the potential to improve clinical outcomes and reduce the number of visits needed for DBS optimization.
The study involves the extraction of data collected during routine clinical care, and data collected during the intervention study.
Data collected during routine clinical care includes:
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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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.
Device: Cerebellothalamic optimized deep brain stimulation · Device: Pallidothalamic optimized deep brain stimulation · Other: No deep brain stimulation · Device: Usual care deep brain stimulation
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.
Device: Cerebellothalamic optimized deep brain stimulation · Device: Pallidothalamic optimized deep brain stimulation · Other: No deep brain stimulation · Device: Usual care deep brain stimulation
A deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model
A deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model
Patients will also be tested without any deep brain stimulation
Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist
Tremor duration as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor duration. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Time frame: Approximately eight hours
Tremor severity as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Time frame: Approximately eight hours
Dyskinesia duration as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity duration). This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Time frame: Approximately eight hours
Dyskinesia severity as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Time frame: Approximately eight hours
Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) tremor severity score ranges from 0 to 4, with higher scores indicating greater severity of tremors.
Time frame: Approximately eight hours
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 10 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
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