Clinical trial for Chronic Pain
Official title Focused Ultrasound Stimulation for the Treatment of Chronic Pain
ClinicalTrials.gov ID: NCT07801443
What this study is testing
- What it's testing
- The study aims to see if using focused ultrasound to stimulate specific brain areas can help manage chronic pain.
- Who it's for
- The study is looking for people who suffer from chronic pain.
- What's involved
- Participants will have an MRI scan to map their brain, then receive ultrasound treatment targeted at specific areas. They will also have their pain levels monitored throughout the process.
- Time commitment
- The study involves an initial MRI scan and ongoing monitoring during the treatment period.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- 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...
You likely can't join if
- Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or...
- 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).
- 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.
See the full eligibility criteria
Who can join
- 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.
- 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...
- 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.
What rules you out
- 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.
- 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).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.