Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have had deep brain stimulation therapy. Participants will compare two different settings to see how they affect Parkinson's symptoms.
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 deep brain stimulation in the subthalamic nucleus or globus pallidus.
It has been at least 3 months since my surgery.
I am between 18 and 85 years old.
I have had a 7T MRI and post-operative CT scan.
You may not be able to join if
I cannot walk without medication or stimulation.
My walking difficulties are caused by a condition other than Parkinson's disease.
I have breaks or shorts in my active contacts.
My battery for the neurostimulator is running low.
I am pregnant or nursing.
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.
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus …
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.
Trial Locations
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Status
Eligibility Criteria
* Diagnosis of Parkinson's Disease
* Bilateral DBS in STN or GP
* At least 3 months after lead implantation
* Montreal Cognitive Assessment (MoCA):
MoCA=23+
OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be p…
* Diagnosis of Parkinson's Disease
* Bilateral DBS in STN or GP
* At least 3 months after lead implantation
* Montreal Cognitive Assessment (MoCA):
MoCA=23+
OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate.
* Between 18-85 years of age
* Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care).
8.2 Exclusion Criteria:
* Inability to walk in the off-med, off-stimulation condition (even with safety harness)
* Gait impaired significantly by a condition other than PD
* Breaks or shorts in active contacts
* IPG battery nearing end of life (in patients with primary-cell IPGs)
* Females who are nursing or pregnant
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