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Physiological Brain Atlas Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Vibhor Krishna, Ohio State University
ClinicalTrials.gov Identifier:
NCT01210534
First received: September 27, 2010
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.

Condition Intervention
Parkinson Disease
Dystonia
Tremors
Obsessive Compulsive Disorder
Depression
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physiological Brain Atlas Development

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • optimal DBS target location [ Time Frame: intra-operative identification ] [ Designated as safety issue: No ]
    To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms.


Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: No intervention
    No intervention
    Other Name: Single Arm Group
Detailed Description:

The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.

The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.

  Eligibility

Ages Eligible for Study:   7 Years to 90 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who are undergoing DBS implantation surgery at the Ohio State University.
Criteria

Inclusion Criteria:

  • Any patient between the age of 7-90

Exclusion Criteria:

  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: NCT01210534

Contacts
Contact: Carson R Reider, PhD 614-293-9274 carson.reider@osumc.edu

Locations
United States, Ohio
The Ohio Sate University Recruiting
Columbus, Ohio, United States, 43210
Contact: Carson Reider    614-293-9274    carson.reider@osumc.edu   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Carson Reider, PhD    614-293-9274    carson.reider@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Vibhor Krishna, MD Ohio State University
  More Information

Responsible Party: Vibhor Krishna, Clinical Assistant Professor of Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT01210534     History of Changes
Other Study ID Numbers: 2010H0036 
Study First Received: September 27, 2010
Last Updated: November 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Dystonia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016