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NCT06083493

Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation

Completed NA Results posted Last updated 19 November 2024
What this trial tests

NA trial testing LIFUP excitation in Thalamus in 61 participants. Completed in 13 June 2024.

Timeline
7 November 2023
Primary endpoint
13 May 2024
13 June 2024

Quick facts

Lead sponsorUniversity of Michigan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposebasic science
Enrollment61
Start date7 November 2023
Primary completion13 May 2024
Estimated completion13 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Michigan

Who can join

Adults 18 to 40, any sex, with Thalamus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Baseline
GroupValue95% CI
LIFUP Excitation0.7452± 0.1128
LIFUP Inhibition0.7419± 0.1250
Following intervention
GroupValue95% CI
LIFUP Excitation0.7520± 0.1014
LIFUP Inhibition0.7120± 0.1674
Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT) Primary · 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).

Baseline
GroupValue95% CI
LIFUP Excitation0.3008± 0.2589
LIFUP Inhibition0.2092± 0.2940
Following intervention
GroupValue95% CI
LIFUP Excitation0.3113± 0.3000
LIFUP Inhibition0.2770± 0.3322

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 32 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LIFUP Excitation
Serious: 0/30 (0%)
Deaths: 0/30
LIFUP Inhibition
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (8 terms — click to expand)

ReactionSystemLIFUP ExcitationLIFUP Inhibition
HeadacheNervous system disorders
FatigueGeneral disorders
Skin Irritation - EarSkin and subcutaneous tissue disorders
Eye IrritationEye disorders
TinnitusEar and labyrinth disorders
DizzinessEar and labyrinth disorders
Muscle SpasmsMusculoskeletal and connective tissue disorders
Blurred VisionEye disorders

Data from ClinicalTrials.gov NCT06083493 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University of Michigan trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06083493.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing