Trial record 7 of 128 for:    Deep Brain Stimulation for Parkinson's Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Su-Youne Chang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01809613
First received: March 11, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.


Condition Intervention
Parkinson Disease
Procedure: Functional Magnetic Resonance Imaging (fMRI)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 6 months after Deep Brain Stimulation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulation-evoked blood-oxygen-level dependence (BOLD) signal
Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS.
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.

Detailed Description:

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) within the thalamocortical basal ganglion (BG) complex is an effective neurosurgical approach for treating motor symptoms of Parkinson's disease (PD). 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 STN DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of thalamocortical BG network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS protocol in order to determine the major sites of activation in the thalamocortical BG complex during application of clinically effective DBS to the dorsal and ventral regions of the STN (dSTN and ventral subthalamic nucleus (vSTN), respectively). Patients will undergo clinical assessment using the Unified Parkinson's Disease Rating Scale (UPDRS) to determine the relative efficacy of dSTN and vSTN DBS, applied during the fMRI and at every standard follow visit post-surgery. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by vSTN and dSTN DBS in PD patients and (2) correlate fMRI activation with clinical outcomes (UPDRS) 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 PD patients.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809613

Contacts
Contact: Emily Knight 507-293-0512 knight.emily@mayo.edu
Contact: Su Youne Chang, PhD 507-255-6443 chang.suyoune@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Emily Knight    507-293-0512    knight.emily@mayo.edu   
Principal Investigator: Su-youne Chang, PhD         
Principal Investigator: Kendall Lee, M.D. Phd         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Su Youne Chang, Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Su-Youne Chang, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01809613     History of Changes
Other Study ID Numbers: 12-009020
Study First Received: March 11, 2013
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Parkinson disease
Deep Brain Stimulation
Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 29, 2014