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NCT06906211 · ClinicalTrials.gov registry record · NA
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
A NA study of Chronic Back Pain and Chronic Pain (Back / Neck), sponsored by Washington D.C. Veterans Affairs Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT06906211: Recruiting NA study of Chronic Back Pain and Chronic Pain (Back / Neck), sponsored by Washington D.C. Veterans Affairs Medical Center.
NCT06906211 is a NA study of Chronic Back Pain and Chronic Pain (Back / Neck) that is actively recruiting participants, run by Washington D.C. Veterans Affairs Medical Center. The registered enrollment target is 66 participants, below the 178-participant average among 7 other Chronic Back Pain trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06906211, a NA study of Chronic Back Pain and Chronic Pain (Back / Neck), is actively recruiting participants, sponsored by Washington D.C. Veterans Affairs Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer: * The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
Primary Outcome
For the first measure, the probe is placed on the skin on the ventral aspect of the forearm on the nondominant arm. The temperature is set at 32°C and the temperature is increased at a rate of 1°C/s to a maximum of 52°C. Participants will be asked to press a button when the heat reaches a painful level. The outcome is the temperature at this level. Heat PT are averaged over three trials each separated by 40 seconds. Thermal PT will be performed prior to and after LIFU. On each trial, the thermod
Conditions Studied
Interventions
- DEVICE low intensity focused ultrasound (LIFU)
Study Locations (1)
District of Columbia
- Washington DC Veterans Affairs Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2028-01-26 |
| Phase | NA |
What NCT06906211 shows while recruiting
NCT06906211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 178-participant average among 7 other Chronic Back Pain trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Chronic Back Pain appearing as the primary indexed condition, and to 1 intervention - of which low intensity focused ultrasound (LIFU) is the first listed.
NCT06906211 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06906211 about?
NCT06906211 is a clinical study titled "Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula". In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main que...
What is the current status of trial NCT06906211?
This trial is currently recruiting. It is a NA study. The enrollment target is 66 participants. The study started on 2025-01-15. Estimated completion is 2028-01-26.
What conditions does trial NCT06906211 study?
This clinical trial studies the following conditions: Chronic Back Pain, Chronic Pain (Back / Neck).
What interventions are being tested in trial NCT06906211?
The interventions under investigation include: low intensity focused ultrasound (LIFU) (DEVICE).
Who is sponsoring clinical trial NCT06906211?
This trial is sponsored by Washington D.C. Veterans Affairs Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06906211 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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