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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIFUP excitation | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sensitivity Derived From the Signal Detection Theory (SDT) | 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). | Up to 60 minutes after intervention |
| Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT) | 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). | Up to 60 minutes after intervention |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Zirui Huang | University of Michigan | Principal Investigator |
| Anthony Hudetz | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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61 participants were consented for this trial. 1 participant was excluded before randomization because of a scheduling conflict.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 61 participants consented, baseline data was not collected from 1 participant who was not randomized and did not participate in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sensitivity Derived From the Signal Detection Theory (SDT) | 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 60 minutes after intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zirui Huang | University of Michigan | 734-615-2875 | huangzu@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2023 | Oct 21, 2024 | Prot_SAP_000.pdf |
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|
| 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. |
|
| Insufficient baseline performance |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Primary | Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT) | 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). | Posted | Mean | Standard Deviation | units on a scale | Up to 60 minutes after intervention |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 3 | 30 |
| Fatigue | General disorders | Systematic Assessment |
|
| Skin Irritation - Ear | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eye Irritation | Eye disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
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