NCT06899022

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Sep 2025Aug 2028

First Submitted

Initial submission to the registry

March 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

May 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 14, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

Deep Brain StimulationAttentionPerceptionEye movement

Outcome Measures

Primary Outcomes (3)

  • Facial Expression Rating

    Participants will rate facial expression along a continuous scale using a computerized slider, following the affective bias task (ABT) of Bijanki et al. (2014). The scale is anchored with three descriptors, "Very Sad" at slider value 0 (left), "Neutral", at position 0.5 (middle), and "Very Happy" at 1.0 (right). Responses are compared between two time points: (1) at the initial pre-surgical testing session and post DBS implantation and (2) at the post-implantation session following clinical optimization of therapeutic parameters, 2-3 weeks after surgery. The comparison will examine both the direction of any bias of the rating, against normative ratings, and the magnitude of average deviation from normative ratings. Finally, the ratings will be incorporated into a generalized linear model of gaze position (Kovach 2014) to identify the association between perceived facial expression and characteristic fixation patterns.

    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

    The location and duration of gaze fixations will be recorded with a remote eye tracking camera. The location of gaze fixations will be treated as the dependent measure within a generalized linear modeling (GLM) framework for spatial point processes, described in Kovach and Adolphs (2014). Parameter estimates of the model give the log relative risk of fixation at different locations in the visual scene as a function of the independent measures of the model. Independent measures include the main effect of (1) Fourier basis functions encoding scene location and its interactions with (2) image rating in the affective bias task of Bijanki et. al (2014), (3) session and (4) DBS stimulation state. Measures derived from the GLM model will also include the statistical deviation (e.g. Kullback-Leibler divergence) from the average distribution of fixations observed in healthy comparison subjects for each image.

    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

    During the Aim 2 portion of the study, patients undergoing awake DBS surgery as part of standard clinical care will engage in a subset of the face rating tasks during the surgery. Invasive recordings will be obtained from DBS target structures, including STN, VIM, and GPi using microelectrodes that are placed as part of standard clinical practice. Spike sorting will be used to identify firing of individual cells and firing rate will compared to eye movements to identify responses associated with shifts of attention in the targeted deep brain structures . These measures will be compared across movement-disorders populations using mixed-effects linear modeling and other standard statistical procedures.

    Intraoperative (Day 0; day of DBS implantation surgery).

Secondary Outcomes (7)

  • EEG beta-band power during emotional face rating

    Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).

  • EEG event-related potential (ERP) amplitude at saccade onset

    Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).

  • EEG beta burst rate, frequency and amplitude during emotional face viewing

    Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).

  • LFP beta-band (12-30 Hz) power during emotional face viewing

    Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).

  • LFP beta burst rate, frequency and amplitude during emotional face viewing

    Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).

  • +2 more secondary outcomes

Study Arms (1)

Acute alteration of DBS

EXPERIMENTAL

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.

Other: Normal therapeutic DBSOther: Reduced current DBSOther: Reduced frequency DBS

Interventions

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

Acute alteration of DBS

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

Acute alteration of DBS

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

Acute alteration of DBS

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Related Publications (104)

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MeSH Terms

Conditions

Essential TremorDystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Christopher K Kovach, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher K Kovach, PhD

CONTACT

Dulce Maroni, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The interventional component of the study examines whether and how altered level and frequency of deep brain stimulation (DBS) acutely affects eye movement and perception of facial emotion. Participants will be tested in 3 stimulation conditions in random order: normal therapeutic DBS, reduced (50%) current DBS at the normal therapeutic frequency and reduced frequency (4 Hz) at the normal therapeutic current.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 27, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations