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

NCT01809613 | Completed

• 1 other identifier: 12-009020
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Obsessive Compulsive Disorder

Keywords

Parkinson disease; Deep Brain Stimulation; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Deep Brain Stimulation

Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS.

Procedure: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Functional Magnetic Resonance Imaging (fMRI) PROCEDURE

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.

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients approved and scheduled to undergo the clinical procedure of Deep Brain stimulation.

You may qualify if:

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

You may not qualify if:

• Pregnant patients, prisoners, children (age less than 18), and any patients identified as unsuitable for this protocol by the Mayo DBS committee.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 26046412 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Mental Disorders

Study Officials

• Kendall Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: March 1, 2013
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

US (1)