Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01113684

Enrollment

175

Registered

2010-04-30

Start date

2010-02-28

Completion date

2014-11-30

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

DEVICEImplantable 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026