Clinical trial NCT01820390: Optimizing DBS Electrode Placement and Programming
Official title: Optimizing DBS Electrode Placement and Programming Using a Combination of High-Field MRI, Intraoperative Electrophysiology, and Computational Modeling.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson's Disease
Essential Tremor
Keywords: Deep Brain Stimulation (DBS)
Parkinson's Disease
Essential Tremor
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the population of patients undergoing DBS surgery at the University of Minnesota Medical Center, for the treatment of (1) Parkinson's disease, or (2) essential tremor.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Distance between Electrophysiology Results and Modeling Predictions (mm)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Department of Neurosurgery, University of Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Aviva D Abosch, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.