Parkinson DiseaseNCT05482126
Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
An observational study of Parkinson Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Intraoperative Behavioral Testing and Behavioral Testing
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 31 Dec 2026
- Phase
- Observational
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical care, as well as healthy controls with no known movement disorder diagnoses
Who may be able to join
- Age >18 years
- Clinically definite, advanced idiopathic PD based on consensus criteria.
- Normal, or essentially normal, preoperative brain MRI.
- Patient is available for follow-up visits over the length of the study
- Patient has elected to undergo DBS surgery as part of routine care, and subthalamic nucleus (STN) is determined as the appropriate surgical target
- Age >18 years.
- No diagnosis of PD, other movement disorder, or other significant neurological disease.
Who cannot join
- Age <18 years.
- Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions that might increase the risk of surgery
- Diagnosis or suspicion of atypical Parkinsonism (PSP, MSA, CBD) or drug-induced Parkinsonism, or significant neurological disease other than PD.
- Diagnosis of psychogenic movement disorder based on consensus criteria
- Prior DBS surgery or ablation
- Clinical dementia and/or Dementia Rating Scale (DRS) score of <5th percentile adjusted for age and education level, based upon routine pre-op NP testing.
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- Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled visit
- Age <18 years.
- Previous diagnosis of PD, other movement disorder, or other significant neurological disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294
About this study
The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available.
Read the detailed description
The purpose of this study is to investigate the functional role of the human basal ganglia in the sensorimotor system. In particular, the investigators are interested in the possibility that the basal ganglia participate in "filtering out" sensory stimuli that are irrelevant to the current behavioral goal. Additionally, the investigators are interested in how this type of sensorimotor processing in these brain areas is related to the severity of movement disorders such as Parkinson's disease and essential tremor.
To do this, the investigators will study both healthy individuals and Parkinson's disease patients undergoing routine deep brain stimulation (DBS) surgery. During the surgery, investigators will place the DBS electrode as routinely performed and additionally place an extra, temporary "strip" electrode along the surface of the brain. Participants will then perform a short behavioral task testing sensorimotor function while investigators record the neural signals from these electrodes. The task will involve the delivery of sensory stimuli (visual, vibrotactile, electrical, and/or proprioceptive), to which the participant will be asked to perform a certain motor response. In order to fully measure the variables of interest, investigators will also attach small stickers (electrodes) to the skin of areas involved in movements for measuring muscle activity (such as the face and limbs), and may attach small, noninvasive devices around the wrist, finger, or arm (e.g., accelerometers) that measure position. The investigators may also apply EEG electrodes to the scalp to measure global brain activity or place a microphone in front of the subject to record speech.
In addition to recording this baseline brain activity, the investigators will evaluate whether deep brain stimulation and dopaminergic medication alters the recorded activity and task performance. Typical deep brain stimulation involves administering specific parameters of high-frequency electrical pulses to achieve clinical benefit. Routine operations involve testing these parameters in the OR in awake patients. For this study, investigators will administer either this high-frequency stimulation or various other patterns of stimulation (e.g., low-frequency, burst stimulation) and measure the changes in behavior and brain activity. As a method of validation, the investigators will also deliver paired pulses of stimulation that enable analysis of stimulation-evoked activity.
Finally, the investigators will correlate recorded brain activity with measures of participants' individual disease severity.
- Conditions
- Parkinson Disease
- Being tested
- Intraoperative Behavioral Testing, Behavioral Testing
- Keywords
- Parkinson, Sensory Processing, Basal Ganglia, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Behavioral TestingDiagnostic test
During DBS surgery, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.
Behavioral TestingDiagnostic test
In the lab, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation Surgery Patients | The investigators will seek to enroll people with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical Receives: Diagnostic Test: Intraoperative Behavioral Testing; Diagnostic Test: Behavioral Testing | |
| Healthy controls | The investigators will seek to enroll a cohort of age- and sex-matched healthy individuals to act as a control group. This group will NOT undergo DBS surgery Receives: Diagnostic Test: Behavioral Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic response to stimulus (intraoperative)
Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.
Measured: Intraoperative
Kinematic response to stimulus (postoperative)
Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.
Measured: 1 month post-op
Latency of response to stimulus (intraoperative)
Time from stimulus onset to start of motor response, measured by electromyography (EMG)
Measured: Intraoperative
Latency of response to stimulus (postoperative)
Time from stimulus onset to start of motor response, measured by electromyography (EMG)
Measured: 1 month post-op
Neural response to stimulus
Brain activity recorded following stimulus onset, measured by local field potentials recorded from the electrocorticography (ECoG) and DBS electrodes.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start8 Jun 2022
- Primary completion1 Aug 2026
- Study completion31 Dec 2026 (estimated)
Why it stopped: Suspending since no longer working participants at this time or enrolling new ones.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, J. Nicole Bentley, University of Alabama at Birmingham
- Investigators
- Nicole Bentley, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482126
- Sponsor's protocol ID
- IRB-300008936
- Other IDs
- R01NS124563
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No