State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

Completed · Phase 1

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.

Key facts

Study ID

NCT02709148

Run by

University of Minnesota

People needed

1

Starts

2017-07-20

Expected to finish

2020-07-31

Last updated by the study team

2021-01-13

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic Parkinson's Disease (PD).
• Age 45-75 years
• UPDRS III motor score (off PD medications) ≥ 25
• Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
• Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
• Cleared to be scanned in a 7 tesla magnet
• Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

You may not qualify if…

• Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
• Evidence of secondary or atypical parkinsonism
• Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
• Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
• Previous pallidotomy or DBS surgery
• Women who are currently pregnant or are breast feeding
• MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
• Any prior intracranial surgery
• Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
• History of seizures
• Immunocompromised
• Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
• Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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