Trial Title:
Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
NCT ID:
NCT05482126
Condition:
Parkinson Disease
Conditions: Official terms:
Ganglion Cysts
Parkinson Disease
Conditions: Keywords:
Parkinson
Sensory Processing
Basal Ganglia
Deep Brain Stimulation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Intraoperative Behavioral Testing
Description:
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.
Arm group label:
Deep Brain Stimulation Surgery Patients
Intervention type:
Diagnostic Test
Intervention name:
Behavioral Testing
Description:
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.
Arm group label:
Deep Brain Stimulation Surgery Patients
Arm group label:
Healthy controls
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.
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria (PD participants):
1. Age >18 years
2. Clinically definite, advanced idiopathic PD based on consensus criteria.
3. Normal, or essentially normal, preoperative brain MRI.
4. Patient is available for follow-up visits over the length of the study
5. Patient has elected to undergo DBS surgery as part of routine care, and subthalamic
nucleus (STN) is determined as the appropriate surgical target
Inclusion criteria (control participants):
1. Age >18 years.
2. No diagnosis of PD, other movement disorder, or other significant neurological
disease.
Exclusion criteria (PD participants):
1. Age <18 years.
2. Medical contraindications such as current uncontrolled hypertension, heart disease,
coagulopathy, or other conditions that might increase the risk of surgery
3. Diagnosis or suspicion of atypical Parkinsonism (PSP, MSA, CBD) or drug-induced
Parkinsonism, or significant neurological disease other than PD.
4. Diagnosis of psychogenic movement disorder based on consensus criteria
5. Prior DBS surgery or ablation
6. 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.
7. Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled
visit
Exclusion criteria (control participants):
1. Age <18 years.
2. Previous diagnosis of PD, other movement disorder, or other significant neurological
disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
89 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The University of Alabama at Birmingham Hospital
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zachary Irwin, PhD
Phone:
205-934-6704
Email:
zirwin@uabmc.edu
Start date:
June 8, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Collaborator:
Agency:
National Institute of Neurological Disorders and Stroke (NINDS)
Agency class:
NIH
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05482126
