An interventional study of Focused PCM-Guided CMN LIFU and Unfocused Control LIFU in Chronic Pain, Sickle Cell Disease and Chronic Pelvic Pain Syndrome, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
Among 12 studies in Chronic Pain by University of Minnesota — 7 open to participants now, 8 under way, none of them phase 3. Chronic Pain · University of Minnesota.
Among the 12 studies in Chronic Pain by University of Minnesota, this one is the only one that started in 2027, is one of 5 with no phase, and was the 12th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →7 of the 12 studies in Chronic Pain by University of Minnesota are open now, in 1 country. Each count lists the studies.
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2027.
Median enrollment 66 across the 8 interventional studies, 58 across the 4 observational. Of the 4 that completed or were terminated, 3 (75%) have results posted.
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
4 of the studies in Chronic Pain by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06617494University of MinnesotaEndogenous Pain Inhibition Deficiency in Chronic TMD Pain | 2026-12-31 |
| NCT04938245University of MinnesotaImproving Spinal Cord Stimulation With ECAPS | 2026-12-31 |
| NCT06696352University of MinnesotaPartners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain | 2027-08 |
| NCT05741788University of MinnesotaThe Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain | 2027-10-01 |
Among the 12 studies in Chronic Pain by University of Minnesota, from their registry updates:
This study will evaluate the feasibility, tolerability, and preliminary analgesic effects of individualized Precision Confidence Mapping-guided low-intensity focused ultrasound neuromodulation in adults with chronic pain.
Participants will undergo MRI and resting-state fMRI to identify an individualized SCAN-connected centromedian thalamic target. Participants will then complete two treatment arms in randomized order: focused centromedian thalamic low-intensity focused ultrasound and unfocused control low-intensity focused ultrasound. Each treatment arm includes five consecutive daily stimulation sessions, separated by a washout interval.
The primary outcome is change in daily pain intensity measured using Brief Pain Inventory pain intensity items. Secondary outcomes include pain-related symptoms, physical function, fatigue, sleep disturbance, depressive symptoms, anxiety symptoms, pain catastrophizing, pain vigilance, neuropathic pain features, feasibility, tolerability, adverse events, blinding integrity, and exploratory neuroimaging measures.
This is a single-site, double-blind, randomized, two-condition crossover feasibility trial evaluating Precision Confidence Mapping-guided low-intensity focused ultrasound neuromodulation in adults with chronic pain.
The study will enroll adults with chronic pain of any etiology, defined as pain present for at least 3 months. The study is designed to include participants across multiple chronic pain populations, including sickle cell disease and chronic pelvic, bladder, or other chronic pain conditions.
Participants will complete an initial screening and a baseline visit that includes informed consent, medical and pain history, baseline questionnaires, MRI safety screening, and 3T MRI. MRI acquisition will include structural imaging, PETRA/pseudo-CT imaging for skull and acoustic modeling, and resting-state fMRI for individualized functional network mapping. Precision Confidence Mapping will be used to identify each participant's individualized SCAN-connected centromedian thalamic target. If an individualized target cannot be identified with sufficient confidence, a probabilistic atlas-based centromedian thalamic target may be used as a fallback.
Participants will then complete two treatment arms in randomized order. In one arm, focused low-intensity focused ultrasound will be delivered to the individualized SCAN-connected centromedian thalamic target using the Attune Neurosciences ATTN201 device. In the other arm, unfocused control low-intensity focused ultrasound will be delivered using the same device placement, acoustic gel application, pulse timing, session duration, and operator interactions, but with randomized element delays designed to minimize focal pressure at the target. Each arm includes five consecutive daily 60-minute sessions.
The two treatment arms will be separated by a washout interval of at least 14 days and up to 90 days. Participants will complete daily pain diaries before, during, and after each treatment arm. The primary analysis will compare within-participant change in daily pain intensity after focused CMN LIFU versus unfocused control LIFU. Secondary and exploratory outcomes will assess pain interference, function, fatigue, sleep, mood, anxiety, pain catastrophizing, neuropathic pain features, feasibility, tolerability, adverse events, blinding integrity, and neuroimaging features associated with treatment response.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this sequence will receive focused PCM-guided centromedian thalamic low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 1, followed by a washout interval, then unfocused control low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 2.
Device: Focused PCM-Guided CMN LIFU · Device: Unfocused Control LIFU
Participants randomized to this sequence will receive unfocused control low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 1, followed by a washout interval, then focused PCM-guided centromedian thalamic low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 2.
Device: Focused PCM-Guided CMN LIFU · Device: Unfocused Control LIFU
Focused low-intensity focused ultrasound will be delivered using the Attune Neurosciences ATTN201 device to an individualized SCAN-connected centromedian thalamic target identified from resting-state fMRI using Precision Confidence Mapping. Stimulation will be delivered once daily for five consecutive treatment days.
Also known as: Focused Centromedian Thalamic Low-Intensity Focused Ultrasound, ATTN201 Low-Intensity Focused Ultrasound System
Unfocused control low-intensity focused ultrasound will use the same device placement, acoustic gel application, pulse timing, session duration, and five-day treatment schedule as focused stimulation. Randomized element delays will be used to produce diffuse acoustic output and negligible focal pressure at the intended deep brain target.
Also known as: Unfocused Control Low-Intensity Focused Ultrasound
Change in Daily Pain Intensity
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.
Time frame: Pre-arm baseline through Days 6 to 7 after each 5-day treatment arm
Change in Pain Interference Measured by the Brief Pain Inventory (BPI) Pain Interference Subscale
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.
Time frame: 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
Change in Physical Function Measured by the PROMIS Physical Function Short Form 6b T-Score
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.
Time frame: 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
Change in Fatigue Measured by the PROMIS Fatigue Short Form 13a T-Score
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.
Time frame: 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
Change in Insomnia Severity Measured by the Insomnia Severity Index (ISI) Total Score
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.
Time frame: 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
Change in Depressive Symptoms Measured by the Patient Health Questionnaire-8 (PHQ-8) Total Score
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.
Time frame: 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
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder-7 (GAD-7) Total Score
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.
Time frame: 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
Change in Pain Catastrophizing Measured by the Pain Catastrophizing Scale (PCS) Total Score
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.
Time frame: 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
Change in Pain Vigilance Measured by the Pain Vigilance and Awareness Questionnaire (PVAQ) Total Score
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.
Time frame: 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
Change in Neuropathic Pain Symptoms Measured by the Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
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.
Time frame: 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
Within-Session Change in Pain Intensity Measured by a 100 mm Visual Analog Scale (VAS)
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.
Time frame: 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
Rate of Enrollment (Participants Enrolled per Month)
Number of participants who sign informed consent divided by the number of months of active recruitment.
Time frame: From the start of recruitment through enrollment of the final participant (target enrollment 80)
Percentage of Randomized Participants Who Complete the Study
Percentage of randomized participants who complete both treatment arms and the Day 7 assessment after Arm 2.
Time frame: From randomization through Day 7 of Arm 2, an average of 4 to 6 months (up to 12 months)
Percentage of Scheduled LIFU Sessions Completed
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.
Time frame: Days 1 to 5 of Arm 1 and Days 1 to 5 of Arm 2
Number of Participants Who Complete All 10 LIFU Sessions
Number and percentage of randomized participants who complete all 5 sessions in both treatment arms.
Time frame: Days 1 to 5 of Arm 1 and Days 1 to 5 of Arm 2, up to 12 months
Percentage of Expected Daily Pain Diary Entries Completed
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.
Time frame: 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 Participants With an Individualized PCM-Derived SCAN-Connected CMN Target
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.
Time frame: Baseline, after Visit 1 MRI processing (approximately 1 to 2 weeks after Visit 1)
Adverse Events and Device Tolerability
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.
Time frame: From consent through final post-treatment monitoring, up to 12 months per participant
Number of Participants Who Correctly Identify Their Treatment Condition
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.
Time frame: Day 5 of Arm 1 and Day 5 of Arm 2 (immediately after the fifth LIFU session)
Distance Between the Individualized PCM-Derived CMN Target and the Atlas-Based CMN Target
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.
Time frame: Baseline (Visit 1 MRI, before Arm 1)
Resting-State Functional Connectivity Between the CMN Target and Cortical SCAN
Functional connectivity between the individualized CMN target and the participant\'s cortical Somato-Cognitive Action Network (SCAN) regions, computed from baseline resting-state fMRI as the Fisher z-transformed Pearson correlation of their time series (unitless; higher values indicate stronger connectivity).
Time frame: Baseline (Visit 1 MRI, before Arm 1)
Minutes of Usable Resting-State fMRI Data After Motion Censoring
Minutes of resting-state fMRI data retained after removing frames with framewise displacement of 0.2 mm or greater.
Time frame: Baseline (Visit 1 MRI, before Arm 1)
Correlation Between Baseline CMN-SCAN Functional Connectivity and Pain Response to Focused CMN LIFU
Spearman correlation coefficient (range -1 to 1) between (1) baseline CMN-to-cortical SCAN functional connectivity (Fisher z-transformed Pearson correlation, measured using (1) baseline resting-state fMRI and (2) change in daily Brief Pain Inventory pain intensity (0 to 10 scale; mean of current, worst, least and average pain) from the pre-arm baseline to Days 6 to 7 after the focused CMN LIFU arm, relative to the same change after unfocused control LIFU.
Time frame: Baseline MRI (Visit 1) and Days 6 to 7 after each treatment arm
Plan to share: No
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