Clinical trial NCT01809613: Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
Official title: Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Essential Tremor
Dystonia
Obsessive Compulsive Disorder
Keywords: Parkinson disease
Deep Brain Stimulation
Functional Magnetic Resonance Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients approved and scheduled to undergo the clinical procedure of Deep Brain stimulation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 6 months after Deep Brain Stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kendall Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knight EJ, Testini P, Min HK, Gibson WS, Gorny KR, Favazza CP, Felmlee JP, Kim I, Welker KM, Clayton DA, Klassen BT, Chang SY, Lee KH. Motor and Nonmotor Circuitry Activation Induced by Subthalamic Nucleus Deep Brain Stimulation in Patients With Parkinson Disease: Intraoperative Functional Magnetic Resonance Imaging for Deep Brain Stimulation. Mayo Clin Proc. 2015 Jun;90(6):773-85. doi: 10.1016/j.mayocp.2015.03.022.