Physiological Brain Atlas Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT01210534
First received: September 27, 2010
Last updated: June 26, 2014
Last verified: June 2014
  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:

Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (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
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:

  • None
  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: Dina Aziz 6143666952 dina.aziz@osumc.edu

Locations
United States, Ohio
The Ohio Sate University Recruiting
Columbus, Ohio, United States, 43210
Contact: Dina Aziz    614-366-3623      
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Dina Aziz    614-366-3623    dina.aziz@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ali Rezai, MD, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT01210534     History of Changes
Other Study ID Numbers: 2010H0036
Study First Received: September 27, 2010
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014