Optimizing DBS Electrode Placement and Programming

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01820390
• Other study ID #: 13-1837
• Status: Withdrawn
• Phase: N/A
• First received: January 14, 2013
• Last updated: February 18, 2014
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Department of Neurosurgery, University of Colorado	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between Electrophysiology Results and Modeling Predictions (mm)	A comparison between electrophysiology results and modeling predictions will be made post-operatively.	1 week	No