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Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
Phase 2 trial testing Low-intensity focused ultrasound pulsation (LIFUP) in Mental Function in 13 participants. Completed in 7 October 2023.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 13 |
| Start date | 26 August 2022 |
| Primary completion | 7 October 2023 |
| Estimated completion | 7 October 2023 |
| Sites | 1 location across United States |
University of Michigan
Adults 18 to 40, any sex, with Mental Function. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
BOLD signal was measured by Magnetic Resonance Imaging (MRI) scanning of the brain in response to a visual stimuli. This method reflected changes in oxygenation of blood in the brain during a scene-processing task.
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.56 | ± 0.03 |
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.51 | ± 0.06 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.56 | ± 0.89 |
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.80 | ± 1.05 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.72 | ± 0.50 |
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 0.39 | ± 0.58 |
Participants' grip force of hand squeezing on a rubber ball in response to instructions was measured.
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 13.8 | ± 5.3 |
| Group | Value | 95% CI |
|---|---|---|
| Central Thalamus (CT) | 11.9 | ± 3.8 |
Time frame: Up to 24 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dorsolateral Prefrontal Co… | Anterior Insula Cortex (AIC) | Central Thalamus (CT) | Sham Control |
|---|---|---|---|---|---|
| Moderate Fatigue | General disorders | — | — | — | — |
| Mild Episode of Apnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Mild Tenderness at IV site | Skin and subcutaneous tissue disorders | — | — | — | — |
| Mild Head Tenderness at Ultrasound Site | Skin and subcutaneous tissue disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT05495945 adverse events section.
The purpose of this study is to see if mental functions take place during different levels of anesthesia. The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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