Physiological Brain Atlas Development

• Sponsor: Ohio State University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01210534
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 180
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Dystonia; Tremors; Obsessive Compulsive Disorder; Depression	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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Physiological Brain Atlas Development
• Study Start Date: Aug 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 1, 2025

Outcome Measures

Primary Outcome Measures

1. optimal DBS target location [intra-operative identification]

   To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio Sate University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vibhor Krishna, Clinical Assistant Professor of Neurological Surgery, Ohio State University
• ClinicalTrials.gov Identifier: NCT01210534
• Other Study ID Numbers: 2010H0036
• First Posted: Sep 28, 2010
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Parkinson Disease; Dystonia; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Oct 19, 2020