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Updated: Jun 12, 2026
A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies
Published on: December 12, 2025
Ethical Considerations in Transcranial Focused Ultrasound Neuromodulation for Disorders of Consciousness
Ally Sterling1, Jason Lew2, Martin M Monti3
1Center for Neurotechnology and Neurorecovery, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA, USA.
Objectives:
Transcranial focused ultrasound stimulation (tFUS), also known as low-intensity focused ultrasound pulsation, may noninvasively modulate key brain networks subserving consciousness and carries promise as a novel interventional tool to stimulate recovery of consciousness in individuals with disorders of consciousness (DoC) after severe brain injury. However, the novelty of this approach and its attendant effects raise underexplored ethical considerations warranting explicit attention to ensure responsible development and deployment in clinical research and practice. Our objectives here are to develop an ethical framework for responsible translation of this emerging neurotechnology.
Materials And Methods:
To identify and critically evaluate the responsible use of tFUS to promote recovery of consciousness in individuals with DoC, we evaluate ethical considerations through the lens of the principles of biomedical ethics, coupled with thematic, normative, and philosophical analysis. We describe safeguards for innovation and clinical translation in this domain.
Results:
Specific ethical domains evaluated include respect for autonomy, beneficence, nonmaleficence, justice, enrollment considerations, and fair study access, which synergistically inform an ethical framework for stakeholders involved in pioneering and early use of tFUS.
Conclusions:
To provide support for clinicians and investigators navigating complex decision-making at the nexus of neurotechnology and neuroethics, we propose a practical checklist for ethical implementation and evaluation of tFUS studies for patients with DoC.
