Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

NCT01113684 | Completed DMC

• 2 other identifiers: F0912150171K23NS067053-01
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

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

Interventions

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.

Also known as: 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

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease who have undergone subthalamic deep brain stimulation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 19625909 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Harrison C Walker, MD

  University of Alabama at Birmingham, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 30, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)