NCT01210534

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2021

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

11.1 years

First QC Date

September 27, 2010

Last Update Submit

February 9, 2023

Conditions

Parkinson DiseaseDystoniaTremorsObsessive Compulsive DisorderDepression

Outcome Measures

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.

    intra-operative identification

Interventions

No interventionOTHER

No intervention

Also known as: Single Arm Group

Eligibility Criteria

Age7 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio Sate University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDystoniaTremorObsessive-Compulsive DisorderDepression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAnxiety DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Vibhor Krishna, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

August 1, 2010

Primary Completion

August 31, 2021

Study Completion

October 18, 2021

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

US(1)