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NCT Number: NCT04061135

Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders

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.

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Key information

Conditions

Movement Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Nicole Bentley, MD

CONTACT

[email protected]

205-975-0011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Response Inhibition and Deep Brain Stimulation in Parkinson's disease

Procedure

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.

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Bentley, MD

CONTACT

[email protected]

205-975-0011

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
Aug 19, 2019
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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