Physiological Brain Atlas Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vanderbilt University
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peter Konrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00575081
First received: December 13, 2007
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

The NIH grant has funded the development of a physiological brain atlas registry that will allow us to significantly improve the targeting and use of DBS implants for Parkinson's Disease, Dystonia, Essential Tremor, and OCD.


Condition Intervention
Parkinson's Disease
Dystonia
Essential Tremor
OCD
Device: Deep Brain Stimulator

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 DBS implantation.


Secondary Outcome Measures:
  • To collate and analyze the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants. [ 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.


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


Estimated Enrollment: 1000
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
Deep Brain Stimulation
Patients who need Deep Brain Stimulation, GPi for Dystonia
Device: Deep Brain Stimulator
Deep Brain Stimulation, GPi for Dystonia
Other Name: Medtronic Deep Brain Stimulator, GPi for Dystonia

Detailed Description:

Purpose:

  1. To create an atlas that will allow physiological 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 DBS implantation at Vanderbilt University.
  2. To collate and analyze 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.
  3. Assist the surgical team intra-operatively in making adjustments in the final DBS target location based on knowledge gained from population data contained within the atlas.
  4. Improve post-implant programming of the DBS unit based on atlas predictions of optimal zones of therapy.

Protocol:

  1. Patients who have consented to undergo or have undergone a DBS implant 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 DBS 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 assistant (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. Dr. Dawant's responsibility will be 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. Targeting for DBS therapy will be analyzed and regularly reported to members of the neurosurgical DBS team regarding accuracy, symptomatic improvement, and any evidence for problems that may appear with inappropriately targeted therapy.
  7. Post-operative programming of the DBS implant will be evaluated with respect to contact location and predicted therapeutic goals based on the atlas. Regular updates regarding optimization of possible improved contact selection will be passed on the clinicians involved in the programming of the DBS implant.
  8. Clinical and physiological data will continue to be entered for every patient who consents to participate in this study for the duration of their care at Vanderbilt University.
  Eligibility

Ages Eligible for Study:   7 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients who have already consented to having DBS surgery for Parkinson's Disease, Dystonia, Essential Tremor, and OCD

Criteria

Inclusion Criteria:

  • All patients who are recommended for DBS surgery by clinical conference
  • Any patient who has agreed to undergo DBS implantation
  • Patients age 7 -90 years old

Exclusion Criteria:

  • Patients who fail recommendation for DBS surgery by clinical conference
  • Patients not consented for dBS surgery
  • Patients outside the age range of 7 -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 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: Joseph S Neimat, MD, MS         
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)
Investigators
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
  More Information

No publications provided

Responsible Party: Peter Konrad, Associate 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: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Physiological Brain Atlas

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

ClinicalTrials.gov processed this record on October 22, 2014