Clinical trial NCT00575081: Physiological Brain Atlas Development
Official title: Physiological Brain Atlas Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Obsessive Compulsive Disorder
Dystonia
Essential Tremor
Epilepsy
Keywords: Physiological Brain Atlas, Brain registry, Brain database
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institute of Mental Health (NIMH)
First posted: 2007-12-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have already consented to having a stereotactic brain procedure for surgical treatment or implantation of a device to treat any brain disease. This includes patients who are undergoing normal neurosurgical care for the treatment of their movement disorder (like tremor and Parkinson's disease), epilepsy, pain, or psychiatric disease.

Brief summary: 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.

Detailed description: Purpose:

1. 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. 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. Dr. Dawant 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 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 6 -90 years old
* Patients or legal guardians not able to provide informed consent

Primary outcomes:
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.
timeFrame: life of study
Secondary outcomes:
measure: 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.
timeFrame: life of study
Other outcomes:
measure: Assist surgical team intro-operatively
timeFrame: life of study
measure: Improve post-implant programming of DBS unit
timeFrame: life of study
Locations:
city: Nashville
country: United States
facility: Vanderbilt Univeristy
state: Tennessee
Study officials:
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Darioq j Englot, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: