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From clinic to home: At-home neuromodulation for depression and the clinical significance of recent FDA approvals.

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Title: From clinic to home: At-home neuromodulation for depression and the clinical significance of recent FDA approvals.
Authors: Altinisik I; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA. Electronic address: idris.altinisik@ttuhsc.edu., Karimi A; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA., Sun E; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA., Molina J; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA.
Source: Journal of affective disorders [J Affect Disord] 2026 Aug 01; Vol. 406, pp. 121716. Date of Electronic Publication: 2026 Mar 30.
Publication Type: Journal Article; Review
Language: English
Journal Info: Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7906073 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2517 (Electronic) Linking ISSN: 01650327 NLM ISO Abbreviation: J Affect Disord Subsets: MEDLINE
Imprint Name(s): Original Publication: Amsterdam, Elsevier/North-Holland Biomedical Press.
MeSH Terms: Transcranial Direct Current Stimulation*/instrumentation , Transcranial Direct Current Stimulation*/methods , Major Depressive Disorder*/therapy , Transcranial Magnetic Stimulation*/methods , Transcranial Magnetic Stimulation*/instrumentation , Device Approval*, Humans ; United States ; United States Food and Drug Administration ; Randomized Controlled Trials as Topic
Abstract: 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.
(Copyright © 2026 Elsevier B.V. All rights reserved.)
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Contributed Indexing: Keywords: At-home treatment; Major depressive disorder; Neuromodulation; Transcranial direct current stimulation; Treatment-resistant depression; tDCS
Entry Date(s): Date Created: 20260401 Date Completed: 20260714 Latest Revision: 20260714
Update Code: 20260714
DOI: 10.1016/j.jad.2026.121716
PMID: 41921873
Database: MEDLINE
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  Data: From clinic to home: At-home neuromodulation for depression and the clinical significance of recent FDA approvals.
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  Data: <searchLink fieldCode="AU" term="%22Altinisik+I%22">Altinisik I</searchLink>; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA. Electronic address: idris.altinisik@ttuhsc.edu.<br /><searchLink fieldCode="AU" term="%22Karimi+A%22">Karimi A</searchLink>; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA.<br /><searchLink fieldCode="AU" term="%22Sun+E%22">Sun E</searchLink>; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA.<br /><searchLink fieldCode="AU" term="%22Molina+J%22">Molina J</searchLink>; Department of Psychiatry, Texas Tech University Health Science Center, Lubbock, TX, USA.
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  Data: <searchLink fieldCode="JN" term="%227906073%22">Journal of affective disorders</searchLink> [J Affect Disord] 2026 Aug 01; Vol. 406, pp. 121716. <i>Date of Electronic Publication: </i>2026 Mar 30.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%2FNorth-Holland+Biomedical+Press%22">Elsevier/North-Holland Biomedical Press </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>7906073 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1573-2517 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201650327%22">01650327 </searchLink><i>NLM ISO Abbreviation: </i>J Affect Disord <i>Subsets: </i>MEDLINE
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  Data: <searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation%22">Transcranial Direct Current Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation+instrumentation%22">instrumentation</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation%22">Transcranial Direct Current Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Major+Depressive+Disorder%22">Major Depressive Disorder*</searchLink>/<searchLink fieldCode="MM" term="%22Major+Depressive+Disorder+therapy%22">therapy</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Magnetic+Stimulation%22">Transcranial Magnetic Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Magnetic+Stimulation+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Magnetic+Stimulation%22">Transcranial Magnetic Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Magnetic+Stimulation+instrumentation%22">instrumentation</searchLink> <br /><searchLink fieldCode="MM" term="%22Device+Approval%22">Device Approval*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22United+States%22">United States</searchLink> ; <searchLink fieldCode="MH" term="%22United+States+Food+and+Drug+Administration%22">United States Food and Drug Administration</searchLink> ; <searchLink fieldCode="MH" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic</searchLink>
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  Data: 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.<br />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.<br />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.<br />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.<br />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.<br />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.<br /> (Copyright © 2026 Elsevier B.V. All rights reserved.)
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  Data: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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  Data: <i>Keywords: </i>At-home treatment; Major depressive disorder; Neuromodulation; Transcranial direct current stimulation; Treatment-resistant depression; tDCS
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