Physiological Brain Atlas Development

Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.

Study Overview

• Status: Completed
• Conditions: Depression; Parkinson Disease; Obsessive Compulsive Disorder; Dystonia; Tremors
• Intervention / Treatment: Other: No intervention

Detailed Description

The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.

The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing 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.

• Study Type: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio Sate University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who are undergoing DBS implantation surgery at the Ohio State University.

Description

Inclusion Criteria:

• Any patient between the age of 7-90
• Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optimal DBS target location	To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms.	intra-operative identification

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Vibhor Krishna, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): October 18, 2021

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (ESTIMATE): September 28, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Anxiety Disorders; Dyskinesias; Parkinson Disease; Obsessive-Compulsive Disorder; Dystonia
• Other Study ID Numbers: 2010H0036