Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable pulse generator (deep brain stimulator)

Device

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.

Other names: 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.)

Primary outcomes

This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease.

Time frame: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Apr 30, 2010
Registry last updated: May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed