Physiological Brain Atlas Development
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-90
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Stereotactic brain procedures
DeviceStereotactic brain procedures
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Stereotactic Brain Procedures1 intervention
Trial outcomes
Primary outcomes
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.
The above data will specifically be acquired from the population of patients undergoing Stereotactic Brain Surgery
Time frame
life of studySecondary outcomes
1
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.
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
Time frame
life of studyOther outcomes
1
Assist surgical team intro-operatively
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.
Time frame
life of study2
Improve post-implant programming of DBS unit
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
Time frame
life of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov