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



Status:Enrolling by invitation
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 75
Updated:5/6/2018
Start Date:July 20, 2017
End Date:July 2020

Use our guide to learn which trials are right for you!

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS

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.

Experimental: chronic brain recording This is a one-arm, single-center study of the
neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of
chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa
PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded
from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS).
2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility
of the use of brain signals as feedback either directly to the patient or for DBS stimulation
adjustments.

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's Disease (PD).

2. Age 45-75 years

3. UPDRS III motor score (off PD medications) ≥ 25

4. Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as
assessed by total UPDRS III score (off and on meds)

5. 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

6. Cleared to be scanned in a 7 tesla magnet

7. Written documentation of willingness to participate in the study per protocol as
evidenced by the informed consent process

Exclusion Criteria:

1. Clinically significant medical disease that would increase the risk of developing pre-
or post-operative complications (e.g., significant cardiac or pulmonary disease)

2. Evidence of secondary or atypical parkinsonism

3. Dementia as evidenced by impairment in two neuropsychological domains and impaired or
borderline neuropsychological function in one additional domain.

4. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted
pacemaker)

5. Previous pallidotomy or DBS surgery

6. Women who are currently pregnant or are breast feeding

7. MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain
lesions that could indicate a non-idiopathic movement disorder

8. Any prior intracranial surgery

9. Subjects with depression defined according to Diagnostic and Statistical Manual V
criteria and a scored on a validated depression assessment scale

10. History of seizures

11. Immunocompromised

12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic
stimulation (TMS) to treat a chronic condition

13. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or
medication pump.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jerrold Vitek, MD, PhD
Phone: 612-626-3525
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials