NCT05482126 · University of Alabama at Birmingham
Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Intraoperative Behavioral Testing
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.
DIAGNOSTIC_TEST
Behavioral Testing
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.
Primary outcome measures
Kinematic response to stimulus (intraoperative)
Time frame: Intraoperative
Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.
Kinematic response to stimulus (postoperative)
Time frame: 1 month post-op
Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.
Latency of response to stimulus (intraoperative)
Time frame: Intraoperative
Time from stimulus onset to start of motor response, measured by electromyography (EMG)
Latency of response to stimulus (postoperative)
Time frame: 1 month post-op
Time from stimulus onset to start of motor response, measured by electromyography (EMG)
Neural response to stimulus
Time frame: Intraoperative
Brain activity recorded following stimulus onset, measured by local field potentials recorded from the electrocorticography (ECoG) and DBS electrodes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (PD participants):
- 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 Inclusion criteria (control participants):
- Age \>18 years.
- No diagnosis of PD, other movement disorder, or other significant neurological disease.
Exclusion criteria
- (PD participants):
- 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.
- Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled visit Exclusion criteria (control participants):
- Age \<18 years.
- Previous diagnosis of PD, other movement disorder, or other significant neurological disease.
Where
- Birmingham, Alabama
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations