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Clinical Trials/NCT05482126
NCT05482126
Recruiting
Not Applicable

Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease

University of Alabama at Birmingham1 site in 1 country30 target enrollmentJune 8, 2022

Overview

Phase
Not Applicable
Intervention
Intraoperative Behavioral Testing
Conditions
Parkinson Disease
Sponsor
University of Alabama at Birmingham
Enrollment
30
Locations
1
Primary Endpoint
Latency of response to stimulus (intraoperative)
Status
Recruiting
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 8, 2022
End Date
December 31, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zachary Irwin

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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.

Arms & Interventions

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

Intervention: Intraoperative Behavioral Testing

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

Intervention: 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

Intervention: Behavioral Testing

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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