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

December 13, 2007
December 20, 2013
August 2006
July 2020   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00575081 on ClinicalTrials.gov Archive Site
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.
Not Provided
  • 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
Not Provided
 
Physiological Brain Atlas Development
Physiological Brain Atlas Development

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

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

  • Parkinson's Disease
  • Dystonia
  • Essential Tremor
  • OCD
Device: Deep Brain Stimulator
Deep Brain Stimulation, GPi for Dystonia
Other Name: Medtronic Deep Brain Stimulator, GPi for Dystonia
Deep Brain Stimulation
Patients who need Deep Brain Stimulation, GPi for Dystonia
Intervention: Device: Deep Brain Stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2020
July 2020   (final data collection date for primary outcome measure)

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
Both
7 Years to 90 Years
No
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
United States
 
NCT00575081
060232, 1R01EB006136-01, 2R01EB006136, 1R41NS063705-01A1, 9R42MH100007-03
Yes
Peter Konrad, Vanderbilt University
Vanderbilt University
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institute of Mental Health (NIMH)
Principal Investigator: Peter E Konrad, MD, Ph.D. Vanderbilt University, Dept. Neurosurgery
Vanderbilt University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP