Trial Outcomes & Findings for Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation (NCT NCT06083493)
NCT ID: NCT06083493
Last Updated: 2024-11-19
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Up to 60 minutes after intervention
Results posted on
2024-11-19
Participant Flow
61 participants were consented for this trial. 1 participant was excluded before randomization because of a scheduling conflict.
Participant milestones
| Measure |
LIFUP Excitation
The 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.
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.
|
LIFUP Inhibition
The 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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
LIFUP Excitation
The 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.
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.
|
LIFUP Inhibition
The 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.
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.
|
|---|---|---|
|
Overall Study
Technical issues with the interventional device
|
2
|
2
|
|
Overall Study
Performed incorrect visual task
|
1
|
0
|
|
Overall Study
Insufficient baseline performance
|
0
|
1
|
Baseline Characteristics
Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
Baseline characteristics by cohort
| Measure |
LIFUP Excitation
n=30 Participants
The 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.
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.
|
LIFUP Inhibition
n=30 Participants
The 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.
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
25.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 minutes after interventionSDT 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).
Outcome measures
| Measure |
LIFUP Excitation
n=27 Participants
The 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.
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.
|
LIFUP Inhibition
n=27 Participants
The 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.
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.
|
|---|---|---|
|
Change in Sensitivity Derived From the Signal Detection Theory (SDT)
Baseline
|
0.7452 units on a scale
Standard Deviation 0.1128
|
0.7419 units on a scale
Standard Deviation 0.1250
|
|
Change in Sensitivity Derived From the Signal Detection Theory (SDT)
Following intervention
|
0.7520 units on a scale
Standard Deviation 0.1014
|
0.7120 units on a scale
Standard Deviation 0.1674
|
PRIMARY outcome
Timeframe: Up to 60 minutes after interventionSDT 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).
Outcome measures
| Measure |
LIFUP Excitation
n=27 Participants
The 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.
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.
|
LIFUP Inhibition
n=27 Participants
The 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.
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.
|
|---|---|---|
|
Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Baseline
|
0.3008 units on a scale
Standard Deviation 0.2589
|
0.2092 units on a scale
Standard Deviation 0.2940
|
|
Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Following intervention
|
0.3113 units on a scale
Standard Deviation 0.3000
|
0.2770 units on a scale
Standard Deviation 0.3322
|
Adverse Events
LIFUP Excitation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LIFUP Inhibition
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LIFUP Excitation
n=30 participants at risk
The 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.
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.
|
LIFUP Inhibition
n=30 participants at risk
The 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.
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation - Ear
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Eye disorders
Eye Irritation
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Ear and labyrinth disorders
Dizziness
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
3.3%
1/30 • Up to 32 days
Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place