NCT00575081

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2006Aug 2026

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
18.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

20 years

First QC Date

December 13, 2007

Last Update Submit

August 9, 2025

Conditions

Keywords

Physiological Brain Atlas, Brain registry, Brain database

Outcome Measures

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

    life of study

Secondary 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.

    life of study

Other Outcomes (2)

  • Assist surgical team intro-operatively

    life of study

  • Improve post-implant programming of DBS unit

    life of study

Study Arms (1)

Stereotactic Brain Procedures

Patients who have consented to undergo or have undergone a stereotactic brain procedure for any reason including those who need Deep Brain Stimulation, SEEG or other brain neurmodulation device implant.

Device: Stereotactic brain procedures

Interventions

Stereotactic brain procedures

Stereotactic Brain Procedures

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Univeristy

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseObsessive-Compulsive DisorderDystoniaEssential TremorEpilepsy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesAnxiety DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Darioq j Englot, MD, Ph.D.

    Vanderbilt University, Dept. Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario J Englot, MD, Ph.D.

CONTACT

Wuraola a Adesinasi

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Neurosurgery Department

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

August 1, 2006

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations