Recruiting

ATTN201

Sponsor:

Attune Neurosciences Inc

Code:

NCT07801443

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

ATTN201 focused ultrasound system

Study Details

Brief summary:

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.

Conditions

Chronic Pain

Study ID

NCT07801443

Start date

Sep 4, 2026

Status verified date

Oct, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Dec 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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 but partial compliance is expected and acceptable.
  • If currently on pain medication, must be at the same stable dose(s) for at least 4 weeks prior to screening and throughout the treatment period.
  • Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the participant, and before screening assessments.
  • Be able to speak, read, and understand English.
  • Be able to use a smartphone and the Attune mobile application.
  • Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
  • Be able to adhere to the treatment protocol and visit schedules.
  • Be judged by the investigator as likely to comply with study procedures and willing to participate in the entirety of the study, including all treatment visits and follow-up assessments through Month 6.
  • Be determined by the investigator to be medically stable at baseline as assessed by medical history and non-significant clinical results of a vital signs examination.
  • Male participants must ensure a condom is used for all sexual intercourse and follow acceptable methods of contraception for their female partner for the entire duration of the study and for 90 days after the final study visit. Male participants should not father a child or donate sperm during this same period.
  • Female participants who are sexually active agree to use two methods of contraception for the duration of the study and for 30 days after the final study visit, or not be of childbearing potential as indicated by one of the following:
  • Has reached natural menopause, defined as ≥12 consecutive months of spontaneous amenorrhea without other known cause;
  • Has had a hysterectomy;
  • Has had bilateral tubal ligation; or
  • Has had a bilateral oophorectomy (with or without a hysterectomy) and greater than 6 weeks have passed since the surgery.
  • Has a vasectomized male partner whose vasectomy was performed at least 6 months prior to screening, with documented absence of sperm.

Exclusion Criteria:

  • Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or prevent completion of study procedures. Stable comorbid conditions (e.g., treated depression, anxiety, insomnia) are permitted.
  • Has active suicidality or suicide attempt in the last 6 months.
  • Has an active, unstable substance use disorder including alcohol use disorder in the past 6 months (except for caffeine and nicotine). Participants on stable medication-assisted treatment (e.g., buprenorphine, methadone, naltrexone) for at least 6 months are eligible.
  • Has a history of moderate-to-severe traumatic brain injury, or mild traumatic brain injury within the past 12 months.
  • Has any contraindications for completing a brain MRI scan.
  • The participant's head does not fit within the MRI head coil (32 or 64 channel) while wearing the MR-compatible device.
  • Is pregnant, is attempting to become pregnant, or is nursing.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or sponsor staff directly involved with this trial.
  • Has a Body Mass Index (BMI) >34 kg/m², as higher BMI may prevent adequate fit within the MRI head coil with the ATTN201 device in place. BMI is calculated by taking the participant's weight in kg and dividing by the participant's height in meters, squared.
  • Has a known allergy or sensitivity to ultrasound gel, silicone, or adhesive materials used in monitoring devices.
  • Has an active skin condition (eczema, psoriasis, rash or active infection) at sensor placement sites that would prevent device wear.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FUS Treatment

3 required CMN FUS sessions on Days 2-3, 5-6, and 8-9; optional 3 additional VPL sessions

Interventions

ATTN201 focused ultrasound system

Head-worn low intensity focused ultrasound

Primary outcome measure

  • Change in Brief Pain Inventory - Short Form (BPI-SF) Pain Severity Subscale Score [ Time Frame: Baseline (Day 0) and Day 14 ]

Central Contacts and Locations

Locations

Attune Neurosciences, Inc.

Recruiting

San Francisco, California, United States, 94107

Contacts

Keith Murphy, PhD

415-658-7001outreach@attuneneuro.com

Attune, San Francisco Clinical Research Center

Recruiting

San Francisco, California, United States, 94107

Contacts

Keith Murphy, PhD

4156587001outreach@attuneneuro.com

Principal Investigator:

Keith Murphy, PhD

More Information

Sponsor

Attune Neurosciences Inc

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Attune Neurosciences Inc on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.