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OpenTrials
Completed

NCT Number: NCT06083493

Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation

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

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Key information

Conditions

Thalamus

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be right-handed.
  • Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision 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: persons needing eyeglasses to achieve 20/20 vision 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.

Treatment and study plan

LIFUP excitation

Device

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.

LIFUP inhibition

Device

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.

Primary outcomes

  1. Change in Sensitivity Derived From the Signal Detection Theory (SDT)

    Time frame: Up to 60 minutes after intervention

    SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal).

  2. Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)

    Time frame: Up to 60 minutes after intervention

    SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant's tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.