Suspended

Optimizing DBS Electrode Placement and Programming Using a Combination of High-Field MRI, Intraoperative Electrophysiology, and Computational Modeling.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Synucleinopathies+7

+ Basal Ganglia Diseases

+ Brain Diseases

From 18 to 70 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: February 20, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Deep brain stimulation (DBS) has become the primary surgical therapy for the treatment of motor symptoms associated with Parkinson's disease (PD), and for essential tremor (ET). Although an effective and relatively safe procedure with expanding indications, opportunities exist for the optimization of the current procedure. The investigators therefore propose, in a group of patients undergoing DBS surgery for the treatment of PD or ET, to use a combination of high-field imaging modalities, intraoperative electrophysiology, external sensor interfaces, and computational modeling, to gather information on the utility of using these techniques to optimize DBS electrode placement and programming.

NCT01820390
Principal SponsorUniversity of Colorado, Denver
Last updated: February 20, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesNeurodegenerative DiseasesParkinsonian DisordersParkinson DiseaseEssential Tremor

Criteria

2 inclusion criteria required to participate
A diagnosis of idiopathic Parkinson's disease or essential tremor
Ability to provide informed consent
4 exclusion criteria prevent from participating
Claustrophobia or other conditions that prevent undergoing MR imaging
Idiopathic dystonia
MMSE score < 23
Significant neurological diagnosis other than PD or ET

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Department of Neurosurgery, University of Colorado

Aurora, United StatesOpen Department of Neurosurgery, University of Colorado in Google Maps

University of Colorado

Aurora, United States
Suspended2 Study Centers