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Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders

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ClinicalTrials.gov Identifier: NCT04061135
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
J. Nicole Bentley, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Movement Disorders Procedure: Response Inhibition and Deep Brain Stimulation in Parkinson's disease Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Parkinson's Disease Patients receiving DBS electrodes
 Procedure: Response Inhibition and Deep Brain Stimulation in Parkinson's disease
After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.
No Intervention: Control
Control subjects will be non-Parkinson's Disease patients with essential tremor


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy via Simon Task (% correct) [ Time Frame: 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)


  2. Response times via Simon Task (sec) [ Time Frame: 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.


  3. Simon Effect on Response times (sec) [ Time Frame: 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

  4. Simon Effect on Accuracy (% correct) [ Time Frame: 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

  5. UPDRS 3 motor score (0-108) [ Time Frame: Baseline ]
    Participants will undergo motor evaluation using the validated United Parkinson's disease Rating Scale (UPDRS) part 3

  6. Dementia Rating Scale Score (0-144 points) [ Time Frame: Baseline ]
    Participants will undergo neuropsychological testing as part of routine care, including the Dementia Rating Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061135


Contacts
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Contact: Nicole Bentley, MD 205-975-0011 jbentley@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Nicole Bentley, MD    205-975-0011    jbentley@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Nicole Bentley, MD University of Alabama at Birmingham
More Information
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Responsible Party: J. Nicole Bentley, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04061135    
Other Study ID Numbers: IRB-300003605
UAB ( Other Identifier: UAB )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J. Nicole Bentley, University of Alabama at Birmingham:
Parkinson's disease
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases