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CompletedNCT01210534Updated Feb 13, 2023

Physiological Brain Atlas Development

An observational study in Parkinson Disease, Dystonia and Tremors, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 7 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-13.

Sponsored by Ohio State University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
456
Ages
7 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Dystonia
  • Tremors
  • Obsessive Compulsive Disorder
  • Depression
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 456 is above the median of 96 across 1,056 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
456 participants (actual)

Interventions

  • OtherNo intervention

    No intervention

    Also known as: Single Arm Group

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: intra-operative identification

07

Study locations

1 site
  • The Ohio Sate University
    Columbus, Ohio 43210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01210534
Lead sponsor
Ohio State University
Responsible party
Sponsor
First posted
Sep 28, 2010
Start date
Aug 2010
Primary completion
Aug 31, 2021
Completion
Oct 18, 2021
Last update
Feb 13, 2023

Study contacts

Vibhor Krishna, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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