Clinical trial NCT04957095: Motor Network Physiology
Official title: Motor Network Physiology Characterization During Deep Brain Stimulation Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Essential Tremor
Keywords: deep brain stimulation
levodopa medication
motor cortex
basal ganglia
thalamus
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Basic science study of effects of therapeutic interventions on intracranial physiology
Primary purpose: BASIC_SCIENCE

Brief summary: The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological disorders, like Parkinson's disease (PD) and essential tremor (ET), cause abnormalities in these brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases and is thought to help patients by modulating brain networks responsible for movement. Levodopa medication is also used to modulate this brain networks in patients with PD. The overall objective is to develop a unified theory of basal ganglia thalamocortical (BGTC) circuit dynamics that accounts for disease symptomatology, movement, and their inter-relationship. The underlying hypothesis, is that the rigidity and bradykinesia of PD are fundamentally related to excessive functional coupling across nodes in the BGTC motor circuit impeding effective information flow. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation, cortical stimulation, and pharmacologic therapy in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease who have been recommended to undergo deep brain stimulation for management of their movement disorder
* Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
* Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes

Exclusion Criteria:

* Patients with recent use (within one week) of anticoagulant or antiplatelet agents
* Neurocognitive testing indicating amnestic cognitive deficits

Primary outcomes:
measure: cortical ECoG and subcortical recordings
timeFrame: baseline
measure: Behavioral assessment
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Nader Pouratian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: