Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease



Status:Recruiting
Conditions:Parkinsons Disease, Neurology, Orthopedic, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 90
Updated:3/25/2017
Start Date:March 2013
End Date:November 2018
Contact:Cindy Stoppel
Email:stoppel.cynthia@mayo.edu

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This study is investigating the usefulness of using functional magnetic resonance imaging
(fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease,
Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The
study may determine the relationship between patterns of brain activation and therapeutic
outcome and/or side effects.

Deep brain stimulation (DBS) is an effective neurosurgical approach for treating motor
disorders including Parkinson's disease (PD), Essential Tremor (ET), and dystonia. Its
therapeutic benefit has led to the application of DBS to a wide spectrum of disorders
including psychiatric conditions, epilepsy, Alzeimer's disease, headache,
obsessive-compulsive disorder (OCD), Tourette syndrome, depression and intractable pain.
However, because the nature of its underlying mechanisms and clinical effects are not fully
understood, precision targeting, decreasing adverse effects, and improving clinical outcomes
represent major clinical and scientific challenges in PD and other disorders treated by DBS.
Our goal is to investigate the inter-relationships between site-specific neural activation
and clinical outcomes during DBS. To do so, we will perform non-invasive functional Magnetic
Resonance Imaging (fMRI) to investigate DBS-mediated activation of neural network circuitry.
Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS or
battery change protocol in order to determine the major sites of activation during
application of clinically effective DBS to the subthalamic nucleus (STN), ventral
intermediate thalamus (VIM), globus pallidus interna (GPi), fornix, nucleus accumbens (NAc),
anterior thalamus and periaqueductal gray matter. Patients will undergo clinical assessment
to determine the relative efficacy of DBS stimulation parameters, applied during the fMRI
and at regularly scheduled post-operative programming visits up to 6 months of follow-up.
Our Specific Aims are to: (1) Identify fMRI-activated brain regions by DBS in patients who
undergo DBS surgery (Patients diagnosed with PD, ET, dystonia, OCD, depression, pain,
Tourette's syndrome, and epilepsy. (2) Correlate fMRI activation with clinical outcomes and
side effects. With the goal of improving DBS electrode targeting for optimal and
reproducible clinical outcomes, these experiments will be the first attempt to relate
site-specific DBS with functional in vivo imaging data and quantitative longitudinal
clinical outcome measures in DBS patients.

Inclusion Criteria:

- Adult Patients with medically intractable Parkinson's Disease who have been approved
for DBS surgery by the interdisciplinary Mayo DBS committee.

Exclusion Criteria:

- Pregnant patients, prisoners, children (age less than 18), and any patients
identified as unsuitable for this protocol by the Mayo DBS committee.
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Kendall Lee, M.D. Phd
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mi
from
Rochester, MN
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