Neuromodulation for Pain Management
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Polytechnic Institute and State University
Disqualifiers: Claustrophobia, Pregnancy, Neurologic disorders, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses low-intensity focused ultrasound (LIFU) to gently stimulate specific areas of the brain. Focused ultrasound can stimulate a specific point of tissue and can be a noninvasive method for acupoint stimulation. It targets people dealing with addiction, pain, and mental health issues who may not respond well to typical treatments. The sound waves temporarily change brain activity, which could help improve their symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes people with active medical disorders or treatments that affect the central nervous system. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of this treatment for pain management?
Research shows that low-intensity focused ultrasound (LIFU) can modulate pain responses in animal models and is a promising non-invasive tool for brain stimulation to manage pain. It has been shown to safely affect brain activity, which could help in pain management.
12345Is low-intensity focused ultrasound (LIFU) safe for humans?
Research shows that low-intensity focused ultrasound (LIFU) is generally safe for humans, with no serious adverse effects reported. Some participants experienced mild to moderate symptoms like neck pain, attention problems, muscle twitches, and anxiety, but these were not severe and often resolved quickly.
12367How is Low-intensity Focused Ultrasound (LIFU) treatment different from other pain management treatments?
Low-intensity Focused Ultrasound (LIFU) is unique because it is a non-invasive treatment that uses sound waves to precisely target and modulate brain activity, unlike traditional methods that may involve surgery or medication. It offers reversible effects and can reach deep brain areas without the need for incisions, setting it apart from other neuromodulation techniques like transcranial magnetic or electrical stimulation.
12358Eligibility Criteria
This trial is for healthy volunteers from any ethnic background who can understand and speak English. It's not suitable for pregnant individuals, those with certain metal implants, a history of significant head injury, claustrophobia, neurological disorders like Parkinson's or epilepsy, active central nervous system conditions such as Alzheimer's, or a history of substance dependence.Inclusion Criteria
Healthy volunteers, all ethnicities, who understand and speak English.
Exclusion Criteria
I have a neurological condition like Parkinson's, Epilepsy, or Essential Tremor.
Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
Contraindications to CT: pregnancy
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Participants receive low-intensity focused ultrasound (LIFU) and undergo fMRI scans to measure changes in brain signaling
3 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
The study tests how low-intensity focused ultrasound (LIFU) affects brain activity related to pain. Participants undergo MRI and CT scans along with LIFU treatment. Changes in brain signals are monitored through fMRI after LIFU while experiencing controlled heat sensations. The study spans over four visits including questionnaires and vital signs monitoring.
1Treatment groups
Experimental Treatment
Group I: LIFU, heat evoked fMRI signalsExperimental Treatment1 Intervention
fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).
Low-intensity Focused Ultrasound is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as LIFU for:
- Research purposes for neurological conditions such as depression, addiction, and pain management
🇪🇺 Approved in European Union as LIFU for:
- Research purposes for neurological conditions such as depression, addiction, and pain management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research InstituteRoanoke, VA
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Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
References
Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research. [2022]This article describes an emerging non-invasive neuromodulatory technology, called low intensity focused ultrasound (LIFU). This technology is potentially paradigm shifting as it can deliver non-invasive and reversible deep brain neuromodulation through acoustic sonication, at millimeter precision. Low intensity focused ultrasound's spatial precision, yet non-invasive nature sets it apart from current technologies, such as transcranial magnetic or electrical stimulation and deep brain stimulation. Additionally, its reversible effects allow for the causal study of deep brain regions implicated in psychiatric illness. Studies to date have demonstrated that LIFU can safely modulate human brain activity at cortical and subcortical levels. Due to its novelty, most researchers and clinicians are not aware of the potential applications and promise of this technique, underscoring the need for foundational papers to introduce the community to LIFU. This mini-review and synthesis of recent advances examines several key papers on LIFU administered to humans, describes the population under study, parameters used, and relevant findings that may guide future research. We conclude with a concise overview of some of the more pressing questions to date, considerations when interpreting new data from an emerging field, and highlight the opportunities and challenges in this exciting new area of study.
Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications. [2019]There is an emerging need for noninvasive neuromodulation techniques to improve patient outcomes while minimizing adverse events and morbidity. Low-intensity focused ultrasound (LIFUS) is gaining traction as a non-surgical experimental approach of modulating brain activity. Several LIFUS sonication parameters have been found to potentiate neural firing, suppress cortical and epileptic discharges, and alter behavior when delivered to cortical and subcortical mammalian brain regions.
MR thermometry imaging for low intensity focused ultrasound modulation of spinal nervous tissue. [2023]Previously in rodent and swine models, we have shown that external low intensity focused ultrasound (liFUS) can be used to modulate pain responses. To ensure no adverse heating events occur with liFUS modulation in a non-invasive manner, we perform initial work in swine to show that magnetic resonance thermometry imaging (MRTI) is capable of measuring
Transcranial Focused Ultrasound Stimulation of Periaqueductal Gray for Analgesia. [2022]Transcranial focused ultrasound (tFUS) is regarded as a promising non-invasive stimulation tool for modulating brain circuits. The aim of this study is to explore the feasibility of tFUS stimulation for analgesia applications.
Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]Single-element low-intensity focused ultrasound (LIFU) is an emerging form of human neuromodulation. Current coupling methods are impractical for clinical bedside use. Here, we evaluate commercially available high-viscosity gel polymer matrices as couplants for human LIFU neuromodulation applications.
A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. [2021]Low intensity transcranial focused ultrasound (LIFU) is a promising method of non-invasive neuromodulation that uses mechanical energy to affect neuronal excitability. LIFU confers high spatial resolution and adjustable focal lengths for precise neuromodulation of discrete regions in the human brain. Before the full potential of low intensity ultrasound for research and clinical application can be investigated, data on the safety of this technique is indicated. Here, we provide an evaluation of the safety of LIFU for human neuromodulation through participant report and neurological assessment with a comparison of symptomology to other forms of non-invasive brain stimulation. Participants (N = 120) that were enrolled in one of seven human ultrasound neuromodulation studies in one laboratory at the University of Minnesota (2015-2017) were queried to complete a follow-up Participant Report of Symptoms questionnaire assessing their self-reported experience and tolerance to participation in LIFU research (Isppa 11.56-17.12 W/cm2) and the perceived relation of symptoms to LIFU. A total of 64/120 participant (53%) responded to follow-up requests to complete the Participant Report of Symptoms questionnaire. None of the participants experienced serious adverse effects. From the post-hoc assessment of safety using the questionnaire, 7/64 reported mild to moderate symptoms, that were perceived as 'possibly' or 'probably' related to participation in LIFU experiments. These reports included neck pain, problems with attention, muscle twitches and anxiety. The most common unrelated symptoms included sleepiness and neck pain. There were initial transient reports of mild neck pain, scalp tingling and headache that were extinguished upon follow-up. No new symptoms were reported upon follow up out to 1 month. The profile and incidence of symptoms looks to be similar to other forms of non-invasive brain stimulation.
Safety Review and Perspectives of Transcranial Focused Ultrasound Brain Stimulation. [2023]Ultrasound is an important theragnostic modality in modern medicine. Technical advancement of both acoustic focusing and transcranial delivery have enabled administration of ultrasound waves to localized brain areas with few millimeters of spatial specificity and penetration depth sufficient to reach the thalamus. Transcranial focused ultrasound (tFUS) given at a low acoustic intensity has been shown to increase or suppress the excitability of region-specific brain areas. The neuromodulatory effects can outlast the sonication, suggesting the possibility of inducing neural plasticity needed for neurorehabilitation. Increasing numbers of studies have shown the efficacy and excellent safety profile of the technique, yet comparisons among the safety-related parameters have not been compiled. This review aims to provide safety information and perspectives of tFUS brain stimulation. First, the acoustic parameters most relevant to thermal/mechanical tissue damage are discussed along with regulated parameters for existing ultrasound therapies/diagnostic imaging. Subsequently, the parameters used in studies of large animals, non-human primates, and humans are surveyed and summarized in terms of the acoustic intensity and the mechanical index. The pulse-mode operation and the use of low ultrasound frequency for tFUS-mediated brain stimulation warrant the establishment of new safety guidelines/recommendations for the use of the technique among healthy volunteers, with additional cautionary requirements for its clinical translation.
A prototype stimulator system for noninvasive Low Intensity Focused Ultrasound delivery. [2016]A prototype Low Intensity Focused Ultrasound (LIFU) stimulator system was developed to evaluate non-invasive neuromodulation in a large animal model. We conducted a feasibility study on a Göttingen minipig, demonstrating reversible, targeted transcranial neuromodulation. The hypothalamus of the minipig was repeatedly stimulated with LIFU which evoked temporally correlated increases in both heart rate and blood pressure.