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NCT01210534 Clinical Trial

Physiological Brain Atlas Development

Depression Clinical Trial

Official title:
Physiological Brain Atlas Development

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01210534
Other study ID # 2010H0036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2010
Est. completion date October 18, 2021

Study information
Verified date February 2023
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 456
Est. completion date October 18, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
United States The Ohio Sate University Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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