- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061135
Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Bentley, MD
- Phone Number: 205-975-0011
- Email: jbentley@uabmc.edu
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Nicole Bentley, MD
- Phone Number: 205-975-0011
- Email: jbentley@uabmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Parkinson's Disease Patients receiving DBS electrodes
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
Baseline
|
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. |
Baseline
|
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
|
Baseline
|
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
|
Baseline
|
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
|
Baseline
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy via Simon Task (% correct)
Time Frame: 6 months
|
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) |
6 months
|
Response times via Simon Task (sec)
Time Frame: 6 months
|
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. |
6 months
|
Simon Effect on Response times (sec)
Time Frame: 6 months
|
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
|
6 months
|
Simon Effect on Accuracy (% correct)
Time Frame: 6 months
|
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
|
6 months
|
UPDRS 3 motor score (0-108)
Time Frame: 6 months
|
Participants will undergo motor evaluation using the validated United Parkinson's disease Rating Scale (UPDRS) part 3
|
6 months
|
Comparison of hemispheric differences in power spectral density (p-value, parametric two-tailed t-test)
Time Frame: 0-3 months
|
We will compare changes in right and left-hemispheric power spectral density
|
0-3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of prefrontal power spectra between outpatient EEG and intraoperative ECOG (correlation coefficient)
Time Frame: 0-6 months
|
Participants will perform the Simon task during pre- and post-operative study visits.
Power spectra will be compared to intraoperative power spectra.
|
0-6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicole Bentley, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300003605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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