Trial · NCT07910396
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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. |
| Secondary | Within-Session Change in Pain Intensity Measured by a 100 mm Visual Analog Scale (VAS) | 0 (pre-stimulation), 20, 40 and 60 minutes during each LIFU session on Days 1 to 5 of Arm 1 and Days 1 to 5 of Arm 2 | Current pain will be rated on a 100 mm Visual Analog Scale, from 0 mm (no pain) to 100 mm (worst pain imaginable), before stimulation (0 minutes) and at 20, 40 and 60 minutes of each LIFU session. Higher scores indicate more pain (worse outcome). Within-session change is the 60-minute rating minus the 0-minute rating (range -100 to 100 mm; negative values indicate pain reduction), averaged across the 5 sessions of each treatment arm and compared between focused CMN LIFU and unfocused control LIFU. |
| Secondary | Rate of Enrollment (Participants Enrolled per Month) | From the start of recruitment through enrollment of the final participant (target enrollment 80) | Number of participants who sign informed consent divided by the number of months of active recruitment. |
| Secondary | Percentage of Randomized Participants Who Complete the Study | From randomization through Day 7 of Arm 2, an average of 4 to 6 months (up to 12 months) | Percentage of randomized participants who complete both treatment arms and the Day 7 assessment after Arm 2. |
| Secondary | Percentage of Scheduled LIFU Sessions Completed | Days 1 to 5 of Arm 1 and Days 1 to 5 of Arm 2 | Number of 60-minute LIFU sessions completed in full divided by the number of sessions scheduled (10 per randomized participant: 5 focused CMN LIFU and 5 unfocused control LIFU), expressed as a percentage and reported by condition. |
| Secondary | Number of Participants Who Complete All 10 LIFU Sessions | Days 1 to 5 of Arm 1 and Days 1 to 5 of Arm 2, up to 12 months | Number and percentage of randomized participants who complete all 5 sessions in both treatment arms. |
| Secondary | Percentage of Expected Daily Pain Diary Entries Completed | From the day after Visit 1 through the end of post-Arm 2 pain monitoring, an average of 4 to 6 months (up to 12 months) | Number of completed daily Pain Diary entries (Brief Pain Inventory pain intensity items, 4 items) divided by the number of expected daily entries for each participant, expressed as a percentage. |
| Secondary | Number of Participants With an Individualized PCM-Derived SCAN-Connected CMN Target | Baseline, after Visit 1 MRI processing (approximately 1 to 2 weeks after Visit 1) | Number of participants with usable baseline MRI for whom Precision Confidence Mapping identifies an individualized SCAN-connected centromedian nucleus (CMN) target. Participants without an individualized target may receive an atlas-based fallback target. The outcome reports the number of participants for whom an individualized target was successfully identified. |
| Secondary | Adverse Events and Device Tolerability | From consent through final post-treatment monitoring, up to 12 months per participant | Adverse events and tolerability will be assessed using pre-session and post-session symptom checklists, participant reports, and PI review of adverse event severity, seriousness, expectedness, and relatedness to study procedures. |
| Secondary | Number of Participants Who Correctly Identify Their Treatment Condition | Day 5 of Arm 1 and Day 5 of Arm 2 (immediately after the fifth LIFU session) | At the end of the fifth session of each treatment arm, participants will be asked whether they believe they received focused or unfocused stimulation during that arm (focused, unfocused, or don't know). The number and percentage of participants whose guess matches their actual assignment will be reported separately for the focused CMN LIFU arm and the unfocused control LIFU arm. |
| Other | Distance Between the Individualized PCM-Derived CMN Target and the Atlas-Based CMN Target | Baseline (Visit 1 MRI, before Arm 1) | Euclidean distance, in millimeters, between each participant\'s individualized SCAN- connected centromedian nucleus (CMN) target identified by Precision Confidence Mapping and the probabilistic atlas-based CMN coordinate, measured in the participant\'s native T1-weighted MRI space. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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