Trial · NCT07910396
Focused Ultrasound Neuromodulation for Chronic Pain
NCT07910396, Not applicable, Not yet recruiting, University of Minnesota
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Focused Ultrasound Neuromodulation for Chronic Pain. Trials, record NCT07910396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910396
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Focused Ultrasound Neuromodulation for Chronic Pain
- NCT number
- NCT07910396
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 80 participants, estimated
- Lead sponsor
- University of Minnesota
- Conditions
- Chronic Pain, Sickle Cell Disease, Chronic Pelvic Pain Syndrome
- Interventions
- Focused PCM-Guided CMN LIFU, Unfocused Control LIFU
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Daily Pain Intensity | Pre-arm baseline through Days 6 to 7 after each 5-day treatment arm | Daily pain intensity will be measured using the Brief Pain Inventory pain intensity items. The daily pain intensity composite will be calculated as the mean of four 0 to 10 ratings: current pain, worst pain, least pain, and average pain over the past 24 hours. The primary analysis will compare within-participant change in daily pain intensity after focused PCM-guided CMN LIFU versus unfocused control LIFU. |
| Secondary | Change in Pain Interference Measured by the Brief Pain Inventory (BPI) Pain Interference Subscale | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Pain interference will be measured with the 7-item Pain Interference subscale of the Brief Pain Inventory, covering general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life over the past week. Each item is rated from 0 (does not interfere) to 10 (completely interferes). The outcome is the mean of the 7 items (range 0-10). Higher scores indicate greater pain interference. Change is calculated as Day 7 minus the pre-arm baseline for each treatment condition. |
| Secondary | Change in Physical Function Measured by the PROMIS Physical Function Short Form 6b T-Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 6b, 6 items each scored 1 to 5 (raw score range 6 to 30). Item responses will be converted to a standardized T-score (U.S. general population mean 50, standard deviation 10). Higher scores indicate better physical function (better outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Fatigue Measured by the PROMIS Fatigue Short Form 13a T-Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a (FACIT-Fatigue), 13 items with a 7-day recall, each scored 1 to 5 (raw score range 13 to 65). Item responses will be converted to a standardized T-score (U.S. general population mean 50, standard deviation 10). Higher scores indicate more fatigue (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Insomnia Severity Measured by the Insomnia Severity Index (ISI) Total Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Insomnia severity will be measured with the 7-item Insomnia Severity Index, administered with a 7-day recall period. Each item is rated from 0 to 4, and the total score ranges from 0 to 28. Higher scores indicate more severe insomnia (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Depressive Symptoms Measured by the Patient Health Questionnaire-8 (PHQ-8) Total Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Depressive symptoms will be measured with the 8-item Patient Health Questionnaire- 8, which asks about the past 2 weeks. Each item is rated from 0 (not at all) to 3 (nearly every day), and the total score ranges from 0 to 24. Higher scores indicate more severe depressive symptoms (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7) Total Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Anxiety symptoms will be measured with the 7-item Generalized Anxiety Disorder-7 scale, which asks about the past 2 weeks. Each item is rated from 0 (not at all) to 3 (nearly every day), and the total score ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Pain Catastrophizing Measured by the Pain Catastrophizing Scale (PCS) Total Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Pain catastrophizing will be measured with the 13-item Pain Catastrophizing Scale. Each item is rated from 0 (not at all) to 4 (all the time), and the total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Pain Vigilance Measured by the Pain Vigilance and Awareness Questionnaire (PVAQ) Total Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Attention to pain will be measured with the 16-item Pain Vigilance and Awareness Questionnaire. Each item is rated from 0 (never) to 5 (always), with 2 items reverse-scored, and the total score ranges from 0 to 80. Higher scores indicate greater vigilance and awareness of pain (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Change in Neuropathic Pain Symptoms Measured by the Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score | Pre-Arm 1 baseline, Day 7 of Arm 1, pre-Arm 2 baseline (after the 14 to 90 day washout), and Day 7 of Arm 2 | Neuropathic pain symptoms will be measured with the Neuropathic Pain Symptom Inventory. The total intensity score is the sum of the 10 symptom descriptor items, each rated from 0 (none) to 10 (worst imaginable), giving a range of 0 to 100. The 2 items on duration and number of pain attacks are not part of the total score. Higher scores indicate more severe neuropathic pain symptoms (worse outcome). Change will be calculated from the pre-arm baseline to Day 7 of the same arm (approximately 2 days after the fifth session) and compared between focused CMN LIFU and unfocused control LIFU. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910396
GET https://conductscience.org/api/trials/v1/NCT07910396/registered?page=2