SERENE Low-Intensity Focused Ultrasound for Cognitive Control
NCT07923461, Not applicable, Not yet recruiting, University of Minnesota
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | SERENE Low-Intensity Focused Ultrasound for Cognitive Control | ClinicalTrials.gov |
| NCT number | NCT07923461 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Minnesota | ClinicalTrials.gov |
| Conditions | Suicidal Ideation, Cognitive Control, Neurocognitive Function | ClinicalTrials.gov |
| Interventions | DIADEM Low-Intensity Focused Ultrasound Neuromodulation | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean Reaction Time During the Multi-Source Interference Task Following LIFU at Different Internal Capsule Sites | Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site | Cognitive control performance will be assessed using the Multi-Source Interference Task (MSIT), a computerized cognitive control task. Reaction time will be measured in milliseconds. The MSIT will be administered in blocks, with one block corresponding to each internal capsule sonication site. Mean reaction time will be calculated separately for each block and compared with baseline MSIT mean reaction time. Lower reaction times indicate faster task performance. | ClinicalTrials.gov |
| Primary | Event-Related EEG Alpha-Band Spectral Power Following LIFU | During post-LIFU MSIT assessment at each internal capsule sonication site | EEG alpha-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB). | ClinicalTrials.gov |
| Primary | Event-Related EEG Theta-Band Spectral Power Following LIFU | During post-LIFU MSIT assessment at each internal capsule sonication site | EEG theta-band activity will be assessed using event-related spectral power during the Multi-Source Interference Task (MSIT) following LIFU. Spectral power will be baseline-normalized using a pre-stimulus reference interval from -500 to -100 milliseconds relative to the target event. Baseline normalization will be performed in the linear power domain, with results expressed in decibels (dB). | ClinicalTrials.gov |
| Primary | Time Course of Mean Reaction Time During the Multi-Source Interference Task Following LIFU | During repeated MSIT assessments across LIFU sonication sessions and through post-treatment follow-up within 2 weeks | The time course of LIFU effects on cognitive control will be evaluated using repeated mean reaction time measurements obtained during the Multi-Source Interference Task (MSIT). Reaction time will be measured in milliseconds and summarized for each assessment block. Mean reaction time will be compared across the repeated assessments to evaluate changes in cognitive control performance over time. Lower values indicate faster task performance. | ClinicalTrials.gov |
| Secondary | Change in MSIT Mean Reaction Time From Baseline Following LIFU at Different Internal Capsule Sites | Baseline and during MSIT task blocks corresponding to each internal capsule LIFU sonication site | Differential response to LIFU across internal capsule stimulation sites will be assessed using mean reaction time during the Multi-Source Interference Task (MSIT), measured in milliseconds. Mean reaction time will be calculated separately for the MSIT block corresponding to each sonication site. Change will be calculated as the mean reaction time following sonication at each site minus the baseline mean reaction time. Negative change values indicate faster responses relative to baseline. Changes will be compared across sonication sites. | ClinicalTrials.gov |
| Secondary | Change in Momentary Active Suicidal Ideation Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary active suicidal ideation will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Passive Suicidal Ideation Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary passive suicidal ideation will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Depression Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary depressive symptoms will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Rumination Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary rumination will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Physical Pain Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary physical pain will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Co-dampening Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary co-dampening will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Hallucination Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary experiences of hallucinations will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
| Secondary | Change in Momentary Persecutory Experience Rating Measured by Ecological Momentary Assessment | Twice daily for 3 days before and 3 days after LIFU | Momentary persecutory experiences will be assessed using a study-adapted ecological momentary assessment (EMA) item delivered through participants' smartphones. Responses are rated on a 5-point Likert scale from 1 to 5. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Multi-Source Interference Task | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)