Attune Neurosciences Inc
ATTN201 is a non-invasive focused ultrasound neurostimulation device that delivers offline MRI-guided non-invasive focused ultrasound to target brain areas. A cranial MRI is obtained before starting treatment while subjects wear a MR-compatible fiducial laced version of the wearable to co-register the cranial coordinate system with transducer coordinates. Simulations will define ultrasound focusing instructions for each patient to specifically target their brain area. For 100+ participants, we will also continuously monitor multiple interstitial pain biomarkers over the course of the intervention.
This is an open-label, single-arm study evaluating the safety, feasibility, and efficacy of delivering low intensity focused ultrasound stimulation of the centromedian nucleus of the thalamus (CMN) using the ATTN201 device for the treatment of chronic pain, with integrated multimodal biomarker monitoring. Following informed consent and a screening (intake) visit, which may be completed either on a separate day before the first on-site visit or on the day of Visit 1 prior to any study procedures, participants will come in for Visit 1 (Day 0) for baseline measurements, safety assessments, MRI,…
Inclusion Criteria: * Have self-reported chronic pain of ≥3 months and \<25 years in duration. * Have an average pain severity of ≥3 on a 0-10 numeric rating scale in the past week. * Be between 22 to 80 years of age (inclusive) on the day of signing informed consent. * Be able and willing to undergo a cranial MRI. * Be willing to use the ATTN201 device during treatment sessions and to attempt use of monitoring devices (Adaptyx Continuous Biomonitor, Epitel REMI EEG, smart watch) during the monitoring period. Participants are informed that continuous wear of monitoring devices is encouraged b…
Head-worn low intensity focused ultrasound
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