NCT01820390

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

January 14, 2013

Last Update Submit

February 18, 2014

Conditions

Parkinson's DiseaseEssential Tremor

Keywords

Deep Brain Stimulation (DBS)Parkinson's DiseaseEssential Tremor

Outcome Measures

Primary Outcomes (1)

  • Distance between Electrophysiology Results and Modeling Predictions (mm)

    A comparison between electrophysiology results and modeling predictions will be made post-operatively.

    1 week

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurosurgery, University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related 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. doi: 10.1227/NEU.0b013e3182676b91.

    PMID: 22791039BACKGROUND

  • 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.

    PMID: 22615980BACKGROUND

  • 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.

    PMID: 22235267BACKGROUND

  • 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.

    PMID: 20644424BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseEssential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aviva D Abosch, M.D., Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

January 14, 2013

First Posted

March 28, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

US(2)