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Parkinson's DiseaseNCT01820390

Optimizing DBS Electrode Placement and Programming

An observational study of Parkinson's Disease and Essential Tremor, run by University of Colorado, Denver at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Parkinson's Disease, Essential Tremor
How many people
0 participants
Where
2 sitesUnited States
Study dates
Mar 2013to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Department of Neurosurgery, University of Colorado

    Aurora, Colorado, 80045

  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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

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.

Keywords
Deep Brain Stimulation (DBS), Parkinson's Disease, Essential Tremor
Medical subject headings
Parkinson Disease, Essential Tremor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance between Electrophysiology Results and Modeling Predictions (mm)

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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJul 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Why it stopped: Funding discontinued.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01820390
Sponsor's protocol ID
13-1837
Status last verified
Feb 2014
First submitted
14 Jan 2013
Last updated
20 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22791039

  • 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.

    PubMed 22615980

  • 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.

    PubMed 22235267

  • 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.

    PubMed 20644424

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease and Essential Tremor, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance between Electrophysiology Results and Modeling Predictions (mm) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01820390, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.

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Optimizing DBS Electrode Placement and Programming | AzTrials