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Physiological Brain Atlas Development (Brain Atlas)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Vanderbilt University
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00575081
First received: December 13, 2007
Last updated: May 11, 2016
Last verified: May 2016
  Purpose
The NIH grant has funded the development of a physiological brain atlas registry that will allow us to significantly improve the data collectioin and use of physiological data into a normalized brain volume. This initially was used to improve DBS implants for Parkinson's Disease, Dystonia, Essential Tremor, and OCD, but now includes data acquired during all stereotactic brain procedures.

Condition Intervention
Parkinson's Disease
Obsessive Compulsive Disorder
Dystonia
Essential Tremor
Epilepsy
Device: Stereotactic brain procedures

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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms. [ Time Frame: life of study ] [ Designated as safety issue: Yes ]
    The above data will specifically be acquired from the population of patients undergoing Stereotactic Brain Surgery


Secondary Outcome Measures:
  • To collate and analyze the physiological atlas in a statistical manner that allows doctors to understand and treat brain disease more precisely and based on population data. [ Time Frame: life of study ] [ Designated as safety issue: Yes ]
    This is based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy and brain disease requiring stereotactic procedures


Other Outcome Measures:
  • Assist surgical team intro-operatively [ Time Frame: life of study ] [ Designated as safety issue: Yes ]
    Assist the surgical team intro-operatively in making adjustments in the final DBS target location based on knowledge gained from population data contained within the atlas.

  • Improve post-implant programming of DBS unit [ Time Frame: life of study ] [ Designated as safety issue: Yes ]
    Improve post-implant programming of the DBS unit based on atlas predictions of optimal zones of therapy; to allow precise relationships to be gvisualized in one anonymized MRI volume, which can lead to new findings across larger populations of subjects in the field of brain science


Estimated Enrollment: 5000
Study Start Date: August 2006
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stereotactic Brain Procedures
Patients who need Deep Brain Stimulation, GPi for Dystonia, and/or patients who have consented to undergo or have undergone a stereotactic brain procedure for any reason
Device: Stereotactic brain procedures
Stereotactic brain procedures

Detailed Description:

Purpose:

To create a brain atlas that will allow physiological and clinical information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms. These data will specifically be acquired from the population of patients undergoing stereotactic brain procedures.

2. To collate and analyze the brain data placed in the atlas in a statistical manner that allows doctors to understand and treat brain disease more precisely and based on population data. For example, this would allow surgeons to predict optimal targeting locations for DBS implants, neurologists to program implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative responses to previous therapies in a larger population of subjects.

3. To allow precise relationships to be visualized in one anonymized MRI volume, which can lead to new findings across larger populations of subjects in the field of brain science.

4. To locate all the data in a HIPAA compliant, anonymized location that clinicians and researchers can access securely without compromising personal healthcare information (PHI).

Protocol:

  1. 1. Patients who have consented to undergo or have undergone a stereotactic brain procedure for any reason will be asked to participate in this study.
  2. Permission from the patient will be sought to allow the entry of all related data to be entered into the atlas database. Specifically, this includes any and all related pre-operative, intra-operative, and post-operative clinical, radiographic, and psychologic testing done for the purposes of the surgery.
  3. The data must be entered in a confidential fashion and secured within a section of the database that can be accessed only by persons authorized to view patient healthcare information (PHI). Persons authorized to enter and view individual PHI must have taken and passed the CITI certification and presented documentation of this credential to the IRB study investigator (Dr. Konrad) or his Clinical Trials Specialist (Melba Isom).
  4. Access to individual patient data within the database can be done through a secure login linked to the person's qualifications to access PHI. The list of authorized persons (such as treating physicians and members of the surgical team) will be determined by Dr. Konrad and updated at least on an annual basis within the database by Dr. Dawant or Dr. D'Haese. Drs. Dawant / D'Haese will be responsible to ensure that PHI is physically and virtually secure within the atlas database.
  5. Once in the database, patient identifiers will be codified and not accessible for any queries outside of those certified in step 3. Non-patient specific information can be analyzed, sorted or queried in response to specific statistical questions by any investigator of the research team or authorized person, as designated by the database developer (Dr. Dawant) or his designee.
  6. Data contained within the atlas will be analyzed and regularly reported to members of the Atlas research team regarding accurate display and representation of the data.
  7. Clinical and physiological data will continue to be entered for every subject who consents to participate in this study for the duration of their care.
  8. If subjects no longer wish to have their data tracked within the atlas, they can call the study coordinator (Melba Isom) and have their name removed from any further data collection from the time of notification forward. All previously collected data will still be accessible and not expunged from the database.
  9. We plan to recruit 5,000 patients from Vanderbilt and participating sites.
  Eligibility

Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who have already consented to having a stereotactic brain procedure for brain disease and movement disorders
Criteria

Inclusion Criteria:

  • All patients who are recommended for Stereotactic Brain procedures
  • Any patient who has agreed to undergo a Stereotactic Brain procedure
  • Patients age under 6 -90 years old

Exclusion Criteria:

  • Patients who fail recommendation for Stereotactic Brain procedures
  • Patients not consented for Stereotactic Brain procedures
  • Patients outside the age range of 0 -90 years old
  • Patients or legal guardians not able to provide informed consent
  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: NCT00575081

Contacts
Contact: Peter E Konrad, MD, Ph.D. 615-343-9822 peter.konrad@vanderbilt.edu
Contact: Melba T Isom, ASB, CCRP 615-875-5853 melba.isom@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Univeristy Recruiting
Nashville, Tennessee, United States, 37232
Contact: Peter E Konrad, MD, Ph.D.    615-343-9822    peter.konrad@vanderbilt.edu   
Contact: Melba T Isom    615-343-9822    melba.isom@vanderbilt.edu   
Sub-Investigator: Benoit Dawant, Ph.D.         
Sub-Investigator: Hong Yu, MD         
Sub-Investigator: Changqing Kao, MD, Ph.D.         
Sub-Investigator: Michael Remple, Ph.D.         
Sponsors and Collaborators
Vanderbilt University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
  More Information

Responsible Party: Peter Konrad, Professor, Director of Functional Neurosurgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00575081     History of Changes
Other Study ID Numbers: 060232  1R01EB006136-01  2R01EB006136  1R41NS063705-01A1  9R42MH100007-03 
Study First Received: December 13, 2007
Last Updated: May 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vanderbilt University:
Physiological Brain Atlas, Brain registry, Brain database

Additional relevant MeSH terms:
Parkinson Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Dystonia
Essential Tremor
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 05, 2016