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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809613
• Other study ID #: 12-009020
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: August 1, 2017
• Start date: March 2013
• Est. completion date: July 27, 2017

Study information

• Verified date: August 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Parkinson Disease

Intervention

Procedure:
• Functional Magnetic Resonance Imaging (fMRI)
During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)	The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.	6 months after Deep Brain Stimulation