Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

NCT ID: NCT01113684

Last Updated: 2018-05-11

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

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-11-30

Brief Summary

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Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Implantable pulse generator (deep brain stimulator)

This study evaluates the effects of subthalamic deep brain stimulation on central and peripheral nervous system activity in patients who have already had brain stimulators placed as a matter of routine clinical care.

Intervention Type DEVICE

Other Intervention Names

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Soletra Implantable Pulse Generator (Medtronic, Inc.) Kinetra Implantable Pulse Generator (Medtronic, Inc.) Activa PC Implantable Pulse Generator (Medtronic, Inc.) Activa RC Implantable Pulse Generator (Medtronic, Inc.)

Eligibility Criteria

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Inclusion Criteria

* Patients with Parkinson disease who have undergone subthalamic deep brain stimulation

Exclusion Criteria

* Patients who are unable to follow verbal instructions
* Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
* Patients who are medically unstable
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Harrison Walker, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harrison C Walker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham, Department of Neurology

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Walker HC, Watts RL, Guthrie S, Wang D, Guthrie BL. Bilateral effects of unilateral subthalamic deep brain stimulation on Parkinson's disease at 1 year. Neurosurgery. 2009 Aug;65(2):302-9; discussion 309-10. doi: 10.1227/01.NEU.0000349764.34211.74.

Reference Type BACKGROUND
PMID: 19625909 (View on PubMed)

Other Identifiers

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1K23NS067053-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F091215017

Identifier Type: -

Identifier Source: org_study_id

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