Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders

Not Applicable

Recruiting

• Conditions: Movement Disorders
• Interventions: Procedure: Response Inhibition and Deep Brain Stimulation in Parkinson's disease

• Registration Number: NCT04061135
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of this study is to investigate the brain activity associated with motor and non-motor symptoms of movement disorders, including Parkinson's disease (PD) and essential tremor. These movement disorders commonly have significant non-motor features, such as depression, cognitive and memory impairment, decreased attention, speech and language disturbances, and slower processing speeds. The investigators are interested in the brain activity associated with these motor and non-motor symptoms, and propose to investigate changes in brain activity while the investigators perform recordings of the surface and deep structures of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Detailed Description

Movement disorders are a prominent cause of disability worldwide. In the United States, it is estimated that more than 4 million people suffer from Parkinson's disease (PD), essential tremor (ET), and dystonia, making them some of the most prevalent of neurologic disorders. Of these, PD is the most common, and is primarily characterized by tremor, rigidity, and bradykinesia. However, though primarily characterized by motor symptoms, many patients also have prominent non-motor features, including depression and cognitive impairment, with deficiencies in processing speed, memory, attention, and learning. Some of the most debilitating cognitive deficiencies include deficits in goal-directed response selection and response inhibition, language, and/or speech difficulties, all of which substantially contribute to reduced quality of life.

Unfortunately, these features of movement disorders are less well-studied and lack effective treatment options, necessitating that new treatments be investigated. Deep brain stimulation (DBS), while a highly effective treatment for the cardinal features of PD, is essentially ineffective for, and can even worsen other cognitive domains, and there are few studies currently investigating how different parameters of DBS may improve these symptoms. In addition, speech abnormalities are common with Parkinson's disease and DBS can sometimes worsen speech problems. These impairments consists primarily of hypophonia, but cognitive deficits can result in actual language disturbance. It is often difficult to know whether the speech problems are related to language processing or articulation (related to the movement disorder). In an effort to begin addressing these questions, we propose to study motor and non-motor symptoms in patients with movement disorders, and to correlate movement and cognition with underlying neural electrophysiology.

Study Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Study Start: 2019-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Eligible for DBS surgery based on multi-disciplinary consensus review
• Have a diagnosis of Parkinson's disease or Essential Tremor
• A minimum of 18 years of age
• Willingness to participate in the paradigms described in the protocol

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Exclusion Criteria

• Inability to provide full and informed consent
• Are not surgical candidates due to co-morbid conditions or pregnancy
• Have not undergone an adequate trial of conservative medical management
• Have a clinical presentation for which DBS surgery is not indicated
• Are not able to participate in study-related activities

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Response Inhibition and Deep Brain Stimulation in Parkinson's disease	Parkinson's Disease Patients receiving DBS electrodes

Primary Outcome Measures

Name	Time	Method
Simon Effect on Response times (sec)	Baseline	Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in response times between congruent and incongruent trials
UPDRS 3 motor score (0-108)	Baseline	Participants will undergo motor evaluation using the validated United Parkinson's disease Rating Scale (UPDRS) part 3
Response times via Simon Task (sec)	Baseline	In the Simon task, participants are instructed to respond with a right or left button press according to the word "RIGHT" or "LEFT" that appears on a screen, regardless of where on the screen it actually appears.; This is a measurement response times (continuous measure, from 0-4000 milliseconds) between correct and incorrect responses.
Accuracy via Simon Task (% correct)	Baseline	In the Simon task, participants are instructed to respond with a right or left button press (Right = Red, Left = Blue) according to how a word is printed on a screen ("RED" or "BLUE"), regardless of the color in which the word is printed.; This is a measurement of accuracy (% correct, ranging from 0-100, with higher scores indicating better performance)
Simon Effect on Accuracy (% correct)	Baseline	Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in accuracy between congruent and incongruent trials
Dementia Rating Scale Score (0-144 points)	Baseline	Participants will undergo neuropsychological testing as part of routine care, including the Dementia Rating Scale

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States