Recruiting

DBS for PD & ET

Sponsor:

University of Nebraska

Code:

NCT06899022

Conditions

Essential Tremor

Parkinson's Disease (PD)

Dystonias

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Normal therapeutic DBS

Reduced current DBS

Reduced frequency DBS

Study Details

Brief summary:

The goal of this observational and interventional study is to understand how therapeutic deep brain stimulation (DBS) affects attention, perception and cognition in participants with Parkinson's disease (PD) and non-PD movement disorders, including essential tremor (ET) and dystonia (DT). The main questions it aims to answer are:

  • Does impaired control of attention and eye movement in PD alter how social cues are perceived and interpreted?
  • Does therapeutic DBS improve or worsen attentional and perceptual deficits for social cues in PD, ET and DT?
  • Can DBS be optimized to restore normal attentional control in PD while remaining an effective therapy for other aspects of the disorder.
  • What do parts of the brain targeted by DBS contribute to the control of attention?

Using an eye tracking camera, investigators will study how participants with PD, ET and DT look at and perceive facial expressions of emotion before and after starting DBS therapy, in comparison to a group of healthy participants without ET, PD, DT or DBS. Participants with PD, ET and DT will see and rate morphed facial expressions on a computer screen in three conditions:

  • Before starting DBS therapy (over approximately 1 hour).
  • In the operating room, during the standard procedure to implant DBS electrodes, while the participant is awake (for no more than 15 minutes).
  • After starting DBS therapy, with brief experimental changes of DBS stimulation level and frequency (over approximately 1 hour).

Conditions

Essential Tremor

Parkinson's Disease (PD)

Dystonias

Study ID

NCT06899022

Start date

Sep 22, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria

  • All Participants (Aim 1):

  • Ability and willingness to provide signed informed consent for this study
  • Ability to express perceptual judgments through a button press or mouse- controlled computerized slider
  • Age 19 - 90 years
  • DBS Participants (Aim 1):

  • Diagnosis of idiopathic Parkinson's disease (PD), essential tremor (ET) or dystonia (DT).
  • Scheduled for new implantation of a therapeutic DBS device targeted to subthalamic nucleus (STN), ventral intermediate nucleus of thalamus (VIM) or internal globus pallidus (GPi)
  • Comparison Participants (Aim 1):

o Selection by age matching to participants in PD group
  • Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 2):

  • Ability and willingness to provide signed informed consent for this study
  • Ability to express perceptual judgments through a button press or mouse- controlled computerized slider
  • Age 19 - 90 years
  • Scheduled for awake DBS implantation with clinical micro-electrode recordings (MER)
  • Willing and able to engage in tasks during an awake surgical procedure
  • Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 3):

  • Ability and willingness to provide signed informed consent for this study
  • Ability to express perceptual judgments through a button press or mouse- controlled computerized slider
  • Age 19 - 90 years
  • Willing to undergo acute manipulations of DBS
  • Able to tolerate acute changes of DBS

Exclusion Criteria

  • All Participants (Aim 1):

  • Corrected visual acuity insufficient to perceptually judge face stimuli
  • Inability to understand task instructions or complete task requirements
  • DBS Participants (Aim 1):

o Insufficient therapeutic control of motor symptoms to engage in tasks requiring button press or use of a mouse to control a slider
  • Healthy Comparison Participants (Aim 1):

o History of neurodegenerative disorder
  • Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 2):

  • Corrected visual acuity insufficient to perceptually judge face stimuli
  • Inability to understand task instructions or complete task requirements
  • Not undergoing awake DBS implantation
  • Uncorrected visual acuity insufficient to perceptually judge face stimuli
  • Parkinson's disease (PD), essential tremor (ET) and dystonia (DT) Participants (Aim 3):

  • Corrected visual acuity insufficient to perceptually judge face stimuli
  • Inability to understand task instructions or complete task requirements
  • Failure of DBS to achieve a therapeutic effect on motor symptoms

Study Design

Enrollment

138 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Acute alteration of DBS

All participants in the single arm of this study will undergo acute alteration of DBS stimulation under three conditions in randomized order over the course of 1 hour.

Interventions

Normal therapeutic DBS

Participants will receive deep brain stimulation delivered at the clinically determined therapeutic frequency and current over approximately 20 min.

Reduced current DBS

Participants will receive deep brain stimulation delivered at the clinically determined therapeutic frequency and reduced (50%) current over approximately 20 minutes.

Reduced frequency DBS

Participants will receive deep brain stimulation delivered at the clinically determined therapeutic current and reduced (4 Hz) frequency over approximately 20 min.

Primary outcome measure

  • Facial Expression Rating [ Time Frame: Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters). ]
  • Eye Tracking [ Time Frame: Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters). ]
  • Intraoperative Microrecordings [ Time Frame: Intraoperative (Day 0; day of DBS implantation surgery). ]

Central Contacts and Locations

Central contacts

Christopher K Kovach, PhD

319-471-3372ckovach@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Christopher K Kovach, PhD

More Information

Sponsor

University of Nebraska

Last update posted

May 5, 2026

Last verified

Mar, 2026

Keywords

  • Deep Brain Stimulation
  • Attention
  • Perception
  • Eye movement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-05-05.