Movement DisordersNCT04061135
Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders
A study testing Response Inhibition and Deep Brain Stimulation in Parkinson's disease in people with Movement Disorders, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Response Inhibition and Deep Brain Stimulation in Parkinson's disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Nicole Bentley, MD, 205-975-0011, jbentley@uabmc.edu
About this study
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.
Read the 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.
- Conditions
- Movement Disorders
- Being tested
- Response Inhibition and Deep Brain Stimulation in Parkinson's disease
- Keywords
- Parkinson's disease
- Medical subject headings
- Movement Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response Inhibition and Deep Brain Stimulation in Parkinson's diseaseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Parkinson's Disease Patients receiving DBS electrodes Receives: Procedure: Response Inhibition and Deep Brain Stimulation in Parkinson's disease |
| Control | No intervention | Control subjects will be non-Parkinson's Disease patients with essential tremor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy via Simon Task (% correct)
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)
Measured: Baseline
Response times via Simon Task (sec)
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.
Measured: Baseline
Simon Effect on Response times (sec)
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
Measured: Baseline
Simon Effect on Accuracy (% correct)
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
Measured: Baseline
UPDRS 3 motor score (0-108)
Participants will undergo motor evaluation using the validated United Parkinson's disease Rating Scale (UPDRS) part 3
Measured: Baseline
Dementia Rating Scale Score (0-144 points)
Participants will undergo neuropsychological testing as part of routine care, including the Dementia Rating Scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Nicole Bentley, University of Alabama at Birmingham
- Investigators
- Nicole Bentley, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061135
- Sponsor's protocol ID
- IRB-300003605
- Other IDs
- UAB
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2019
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological, Behavioral, and Cognitive Networks in Movement Disorders
- ClinicalTrials.gov ID
- NCT04061135
- Acronym / sponsor ID
- IRB-300003605
- Conditions
- Movement Disorders
- Keywords
- Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Response Inhibition and Deep Brain Stimulation in Parkinson's diseaseParkinson's Disease Patients receiving DBS electrodes |
| Control | No intervention | –Control subjects will be non-Parkinson's Disease patients with essential tremor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response Inhibition and Deep Brain Stimulation in Parkinson's diseaseAfter 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. | Procedure or surgery | Treatment |
Primary outcome
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)
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.
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Bentley, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response Inhibition and Deep Brain Stimulation in Parkinson's disease in people with Movement Disorders, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Bentley, MD (205-975-0011, jbentley@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy via Simon Task (% correct) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.