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Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06083493
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the role that the thalamus (the egg-shaped structure in the middle of your brain) plays in perception using a low-intensity ultrasound pulsation (LIFUP) device. The researchers expect to observe differential changes in the perceptual outcomes based on the LIFUP stimulation of different thalamic areas

Condition or Disease Intervention/Treatment Phase
  • Device: LIFUP excitation
  • Device: LIFUP inhibition
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LIFUP excitation

Our study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.

Device: LIFUP excitation
The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.
Experimental: LIFUP inhibition

Our study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.

Device: LIFUP inhibition
The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity derived from the Signal Detection Theory (SDT) [Up to 60 minutes after intervention]

    Sensitivity measures a subject's ability to differentiate between trials with a target present and trials with a target absent

  2. Perceptual criterion derived from the Signal Detection Theory (SDT) [Up to 60 minutes after intervention]

    Criterion represents a subject's tendency to report subjective recognition of a target stimulus, irrespective of its presence or absence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Must be right-handed.

  • Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: if you need eyeglasses to achieve 20/20 vision, you cannot be included in this study as eyeglasses cannot be worn during the study visit.

  • Must not be on any medications for any neurological, psychological, or psychiatric conditions.

  • Must be English speaking.

  • Must be capable of giving written informed consent.

Exclusion Criteria:

• Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.

Please note: if you need eyeglasses to achieve 20/20 vision, you cannot be included in this study as eyeglasses cannot be worn during the study visit.

  • History of significant head injury with loss of consciousness.

  • Learning disability or other developmental disorder.

  • Medication use for any neurological, psychological, or psychiatric conditions.

  • Any impairment (sensory or motor loss), activity, or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Zirui Huang, University of Michigan
  • Principal Investigator: Anthony Hudetz, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zirui Huang, Research Assistant Professor, Anesthesiology and Research Fellow, Anesthesiology, University of Michigan
ClinicalTrials.gov Identifier:
NCT06083493
Other Study ID Numbers:
  • HUM00240514
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Zirui Huang, Research Assistant Professor, Anesthesiology and Research Fellow, Anesthesiology, University of Michigan
Perception

Study Results

No Results Posted as of Oct 16, 2023