Journal of affective disorders · 2026
From clinic to home: At-home neuromodulation for depression and the clinical significance of recent FDA approvals.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Altinisik Idris, Karimi Alikhan, Sun Edward, Molina Jules
Аннотация
BACKGROUND: Electroconvulsive therapy achieves response rates of 70-80%, but it requires anesthesia, recovery time, and infrastructure that most patients cannot easily access. Transcranial magnetic stimulation avoids anesthesia yet still demands daily clinic visits, often for six weeks. The gap between what neuromodulation can accomplish and how few patients actually receive it has been a persistent frustration in clinical psychiatry.
RECENT DEVELOPMENTS: The FDA granted premarket approval to two at-home devices for major depression within five weeks of each other: Flow FL-100 (a transcranial direct current stimulation headset, approved December 8, 2025) and ProLiv™Rx (which uses combined occipital and trigeminal nerve stimulation, approved January 12, 2026). These are the first prescription neuromodulation treatments for depression that patients in the United States can administer themselves at home.
OBJECTIVE: We review the pivotal trial data for each device, consider the biological rationale for each approach, and discuss how clinicians might incorporate these tools into practice.
METHODS: We examined the randomized controlled trial evidence behind each approval alongside FDA documents and placed these findings in context with the broader neuromodulation and tDCS literature.
RESULTS: In the Empower trial, Flow FL-100 achieved remission in 44.9% of participants versus 21.8% with sham stimulation (number needed to treat = 4) over 10 weeks. The MOOD trial of ProLiv™Rx, conducted in patients who had already failed antidepressants, demonstrated remission rates of 21.3% versus 6.0% with sham (NNT = 7) at 8 weeks. Both devices were well tolerated.
CONCLUSIONS: These approvals represent a genuine shift in how neuromodulation can be delivered. Whether the early promise holds up in routine clinical practice-and in which patients-remains to be determined, but the possibility of extending brain stimulation beyond specialty clinics is now a reality rather than an aspiration.
RECENT DEVELOPMENTS: The FDA granted premarket approval to two at-home devices for major depression within five weeks of each other: Flow FL-100 (a transcranial direct current stimulation headset, approved December 8, 2025) and ProLiv™Rx (which uses combined occipital and trigeminal nerve stimulation, approved January 12, 2026). These are the first prescription neuromodulation treatments for depression that patients in the United States can administer themselves at home.
OBJECTIVE: We review the pivotal trial data for each device, consider the biological rationale for each approach, and discuss how clinicians might incorporate these tools into practice.
METHODS: We examined the randomized controlled trial evidence behind each approval alongside FDA documents and placed these findings in context with the broader neuromodulation and tDCS literature.
RESULTS: In the Empower trial, Flow FL-100 achieved remission in 44.9% of participants versus 21.8% with sham stimulation (number needed to treat = 4) over 10 weeks. The MOOD trial of ProLiv™Rx, conducted in patients who had already failed antidepressants, demonstrated remission rates of 21.3% versus 6.0% with sham (NNT = 7) at 8 weeks. Both devices were well tolerated.
CONCLUSIONS: These approvals represent a genuine shift in how neuromodulation can be delivered. Whether the early promise holds up in routine clinical practice-and in which patients-remains to be determined, but the possibility of extending brain stimulation beyond specialty clinics is now a reality rather than an aspiration.