At-home neuromodulation is changing psychiatric practice, with new approvals in depression and PTSD
STUDY: Unpublished tria led by Peter Colvonen PhD
STUDY TYPE: Randomized, sham-controlled trial
FUNDING: Neurovalens (device manufacturer)
On May 26, 2026, the FDA approved the first at-home neuromodulation device for PTSD. Modius Spero delivers low-level electrical stimulation through a headphone-like device. It does not affect the brain directly, but works indirectly through the sensory nerve that codes information about balance and position. In that way, it is similar to ProLivRx, an at-home device approved for depression.
The device is worn around the head and stimulates the skin behind each ear for 30 minutes daily. This stimulation travels from the vestibular nerve (cranial nerve VIII) to the brainstem and hypothalamus, targeting the areas that regulate circadian rhythms, sleep patterns, and the stress response.
The clinical trial behind this approval compared Modius Spero to a sham (fake) treatment in 383 adults over 12 weeks. The results are not published, but reportedly two-thirds had a meaningful improvement with the treatment. Modius Spero is approved for ages 22 and older.
An earlier device from the same company, Modius Sleep, is approved for insomnia.
Modius Spero will be available by prescription to US military veterans starting in July 2026 through the VA system.
Practice Implications
- Modius Spero follows Flow and ProLivRx as the third at-home neuromodulation device approved in the past year.
- Previous neurmodulation devices, like TMS, required treatment as specialized offices. These new devices bring neuromodulation mainstream, part of every psychiatric practice along with medications and psychotherapy.
- VA clinicians can sign up to provide this therapy. It is not clear if will be available outside the VA, but the cost is $2,265.
- While we await more details from Neurovalens, you can sign up for ProLivRx here.
— Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report
