Trial Summary
What is the purpose of this trial?This trial is testing a new treatment that uses sound waves directed at specific parts of the brain to help reduce pain. It targets patients with ongoing neuropathic pain that hasn't been managed well by other treatments. The sound waves aim to improve the function of brain areas that process pain signals. This noninvasive treatment option has shown promise in treating chronic neuropathic pain.
Eligibility Criteria
This trial is for adults who have ongoing neuropathic pain, confirmed by imaging or sensory signs, and haven't found relief after trying at least three different medications like antidepressants, anticonvulsants, or opioids. It's not suitable for those unable to consent, stay still during treatment, pregnant or breastfeeding women, or individuals with scalp conditions.Inclusion Criteria
I am 18 years old or older.
I have tried at least 3 different medications for my condition without success.
I have experienced nerve pain, including when it started, where it hurts, how bad it is, how long it lasts, what it feels like, and what makes it worse.
+1 more
Exclusion Criteria
I have a scalp rash or open wounds on my scalp.
Pregnancy, women who may become pregnant or are breastfeeding
I cannot stay still when lying down in a calm environment.
+1 more
Participant Groups
The study tests focused ultrasound technology on the VPM and VPL thalamic nuclei in the brain as a potential treatment for neuropathic pain. The goal is to see if this non-invasive method is tolerable and shows early signs of effectiveness in reducing pain symptoms.
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
Patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the thalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.
Focused Ultrasound is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Gemzar for:
- Metastatic breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
🇪🇺 Approved in European Union as Gemzar for:
- Metastatic breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Neurological Associates of West LASanta Monica, CA
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Who Is Running the Clinical Trial?
Neurological Associates of West Los AngelesLead Sponsor