Optimizing DBS Electrode Placement and Programming

NCT ID: NCT01820390

Last Updated: 2014-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease Essential Tremor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of idiopathic Parkinson's disease or essential tremor
* Ability to provide informed consent

Exclusion Criteria

* Claustrophobia or other conditions that prevent undergoing MR imaging
* MMSE score \< 23
* Significant neurological diagnosis other than PD or ET.
* Idiopathic dystonia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aviva D Abosch, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Department of Neurosurgery, University of Colorado

Aurora, Colorado, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Abosch A, Lanctin D, Onaran I, Eberly L, Spaniol M, Ince NF. Long-term recordings of local field potentials from implanted deep brain stimulation electrodes. Neurosurgery. 2012 Oct;71(4):804-14. doi: 10.1227/NEU.0b013e3182676b91.

Reference Type BACKGROUND
PMID: 22791039 (View on PubMed)

Duchin Y, Abosch A, Yacoub E, Sapiro G, Harel N. Feasibility of using ultra-high field (7 T) MRI for clinical surgical targeting. PLoS One. 2012;7(5):e37328. doi: 10.1371/journal.pone.0037328. Epub 2012 May 17.

Reference Type BACKGROUND
PMID: 22615980 (View on PubMed)

Lenglet C, Abosch A, Yacoub E, De Martino F, Sapiro G, Harel N. Comprehensive in vivo mapping of the human basal ganglia and thalamic connectome in individuals using 7T MRI. PLoS One. 2012;7(1):e29153. doi: 10.1371/journal.pone.0029153. Epub 2012 Jan 3.

Reference Type BACKGROUND
PMID: 22235267 (View on PubMed)

Ince NF, Gupte A, Wichmann T, Ashe J, Henry T, Bebler M, Eberly L, Abosch A. Selection of optimal programming contacts based on local field potential recordings from subthalamic nucleus in patients with Parkinson's disease. Neurosurgery. 2010 Aug;67(2):390-7. doi: 10.1227/01.NEU.0000372091.64824.63.

Reference Type BACKGROUND
PMID: 20644424 (View on PubMed)

Other Identifiers

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13-1837

Identifier Type: -

Identifier Source: org_study_id

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