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Peer-reviewedCC BY-NC-NDNeuromodulation : journal of the International Neuromodulation Society

An updated prospective quantitative analysis of symptoms and safety for human low-intensity focused ultrasound neuromodulation

  • Aditya Kapoor1
  • Thomas Crahan2
  • Wynn Legon1,2,3,4,5,6,7
7 affiliations
  1. 1Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA
  2. 2Virginia Tech Carilion School of Medicine, Roanoke, VA, 24016, USA
  3. 3Center for Human Neuroscience Research, Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA
  4. 4Center for Health Behaviors Research, Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA
  5. 5School of Neuroscience, Virginia Polytechnic Institute and State University, Blacksburg, VA, 24016, USA
  6. 6Graduate Program in Translational Biology, Medicine, and Health, Virginia Polytechnic Institute and State University, Roanoke, VA, 24016, USA
  7. 7Department of Neurosurgery, Carilion Clinic, Roanoke, VA, 24016, USA
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Abstract

OBJECTIVES: Low-intensity focused ultrasound (LIFU) is a noninvasive neuromodulation technique with a favorable safety profile in healthy volunteers. Participant-experienced symptoms, however, remain inconsistently measured, and prospective benchmarks are lacking. Here, we prospectively characterized symptoms associated with LIFU neuromodulation across eight studies using a standardized Report of Symptoms (ROS). MATERIALS AND METHODS: ; mechanical index 0.5-1.4). The ROS rated 17 symptom domains from 0 (absent) to 3 (severe) before and after each session. New-onset incidence, symptom severity, and total symptom burden were compared between LIFU and sham. The same instrument was applied in 35 patients with chronic pain. Symptom profiles after LIFU were indistinguishable from sham across all 17 domains. RESULTS: The total symptom burden averaged approximately one domain per session and did not increase after LIFU (0.94-1.03; p = 0.120). The postintervention burden was predicted by the baseline burden (β = 0.344, p < 0.001) but not by the stimulation condition (p = 0.226). New-onset symptoms did not increase across up to 27 LIFU sessions (odds ratio = 0.99, p = 0.73) and were weakly and nonsignificantly related to acoustic intensity (ρ = 0.37). CONCLUSION: Across a prospective, sham-controlled data set, LIFU added no measurable symptom burden and was well tolerated in healthy adults, with comparable tolerability in patients. These findings establish a benchmark for the safety of human LIFU neuromodulation and a foundation for its therapeutic translation.

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Cite

BibTeXRIS
BibTeX
@article{kapoor2026updated,
  title = {{An updated prospective quantitative analysis of symptoms and safety for human low-intensity focused ultrasound neuromodulation}},
  author = {Aditya Kapoor and Thomas Crahan and Wynn Legon},
  journal = {Neuromodulation : journal of the International Neuromodulation Society},
  year = {2026},
  month = oct,
  doi = {10.1016/j.neurom.2026.09.030},
  url = {https://doi.org/10.1016/j.neurom.2026.09.030},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - An updated prospective quantitative analysis of symptoms and safety for human low-intensity focused ultrasound neuromodulation
AU  - Aditya Kapoor
AU  - Thomas Crahan
AU  - Wynn Legon
PY  - 2026
DA  - 2026/10/09
JO  - Neuromodulation : journal of the International Neuromodulation Society
DO  - 10.1016/j.neurom.2026.09.030
UR  - https://doi.org/10.1016/j.neurom.2026.09.030
AB  - OBJECTIVES: Low-intensity focused ultrasound (LIFU) is a noninvasive neuromodulation technique with a favorable safety profile in healthy volunteers. Participant-experienced symptoms, however, remain inconsistently measured, and prospective benchmarks are lacking. Here, we prospectively characterized symptoms associated with LIFU neuromodulation across eight studies using a standardized Report of Symptoms (ROS). MATERIALS AND METHODS: ; mechanical index 0.5-1.4). The ROS rated 17 symptom domains from 0 (absent) to 3 (severe) before and after each session. New-onset incidence, symptom severity, and total symptom burden were compared between LIFU and sham. The same instrument was applied in 35 patients with chronic pain. Symptom profiles after LIFU were indistinguishable from sham across all 17 domains. RESULTS: The total symptom burden averaged approximately one domain per session and did not increase after LIFU (0.94-1.03; p = 0.120). The postintervention burden was predicted by the baseline burden (β = 0.344, p < 0.001) but not by the stimulation condition (p = 0.226). New-onset symptoms did not increase across up to 27 LIFU sessions (odds ratio = 0.99, p = 0.73) and were weakly and nonsignificantly related to acoustic intensity (ρ = 0.37). CONCLUSION: Across a prospective, sham-controlled data set, LIFU added no measurable symptom burden and was well tolerated in healthy adults, with comparable tolerability in patients. These findings establish a benchmark for the safety of human LIFU neuromodulation and a foundation for its therapeutic translation.
SN  - 1094-7159
SN  - 1525-1403
ER  -