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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 89
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for patients with Parkinson's disease who have had deep brain stimulation (DBS) surgery. Participants will have their brain scans used to create personalized settings for their neurostimulator to improve their movement and balance.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease.
I have had bilateral deep brain stimulation.
I have a directional DBS electrode system.
I had an MRI at least 7 Tesla before my DBS surgery.
I had a head CT after my DBS surgery.
At least 3 months have passed since my neurostimulator was activated.
You may not be able to join if
I have a neurological or musculoskeletal disorder that affects my movement.
I have dementia.
I have had prior brain surgery other than DBS for movement disorder.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neu…
Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. Then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. In STN DBS: pedunculopallidal vs. pallidopeduncular pathways. In GP DBS: pallidopeduncular pathways at its origin in GP pars interna (GPi) vs. inhibitory afferents to GPi (from GP pars externa GPe). All stimulation falls within the the FDA-approved range for DBS for PD.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of PD
* Bilateral DBS
* Directional DBS electrode system
* MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery
* Head CT, at least 1mm cuts, following DBS surgery
* At least 3 months since initial activation of the neurostimulator
Exclusion Cr…
Inclusion Criteria:
* Diagnosis of PD
* Bilateral DBS
* Directional DBS electrode system
* MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery
* Head CT, at least 1mm cuts, following DBS surgery
* At least 3 months since initial activation of the neurostimulator
Exclusion Criteria:
* Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements
* Dementia
* Prior stereotactic neurosurgery other than DBS for movement disorder
* Pregnancy
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