Lindus Health and Sooma Medical Launch Phase 3 Trial for Transcranial Direct Current Stimulation in Treating MDD

Author(s):

A new transcranial direct current stimulation device received approval from the FDA for an investigational device exemption, prompting a phase 3 trial.

Justlight/AdobeStock

Lindus Health and Sooma Medical announced a collaboration on a phase 3 clinical trial to evaluate the effectiveness of Sooma’s transcranial direct current stimulation (tDCS) medical device in treating major depressive disorder (MDD). The trial aims to validate the safety and efficacy of Sooma 2GEN as a home-based treatment, potentially bringing a novel, noninvasive treatment to patients.¹

“Until now, early-stage treatment options have been limited for patients who don’t respond to medication or lack access to therapy,” said Tuomas Neuvonen, CEO of Sooma Medical. “We offer an effective and accessible approach to treating MDD, ensuring everyone with depression receives the right treatment that suits their individual needs.”¹

The news of the phase 3 study comes after the tDCS device received approval from the US Food and Drug Administration (FDA) for an investigational device exemption March 11. The device previously received a Breakthrough Device Designation from the FDA on March 2023. The approval has paved the path toward for the study assessing the device in treating MDD.²

Sooma developed the product to offer a flexible and accessible treatment solution. tDCS relieves depressive symptoms by balancing neuronal excitability at the left dorsolateral prefrontal cortex with a weak current through the skull.³ The trial will enroll approximately 200 participants across the US. Lindus Health will provide virtual site capabilities and digital advertising for patient recruitment, and will oversee in-house medical monitoring. Lindus will also be using its eClinical platform, Citrus, for patient prescreening, virtual study visits with clinicians and research coordinators, submission of patient-reported outcomes, and study oversight.¹

“As the principal investigator, I am honored to lead this pivotal trial evaluating the effectiveness of the Sooma 2GEN device… we are not only aiming to validate this promising therapy but also employ new methodologies that allow trial participation regardless of geographic location,” said Christopher Reist, MD, principal investigator of the study.

Sooma 2GEN is a cap-like device that delivers low-level electrical currents to the brain. A 2022 study done using the Sooma tDCS head cap device found that after the completion of the tDCS treatment, 96.6% of patients had improved from baseline using the Hamilton Depression Rating Scale (HDRS), the Montgomery-Åsberg Depression Rating Scale (MADRS), and major depression inventory.³ Treatment with the tDCS cap consisted of 5 sessions a week for 3 weeks, followed by 3 sessions a week for 7 weeks, followed by a 10 week open label phase. Each session lasted 30 minutes. Of the 410 participants, 19.5% achieved remission within the median follow up time of 21 weeks. Adverse effects included skin itching under the electrodes while in use (44.1%), headaches (24.6%) and skin redness (17.8%).³ The study did not include a placebo group.

Michael Young, cofounder of Lindus Health, emphasized the significance of the study. “We know firsthand that any one particular therapy or class of medications doesn’t necessarily work for all patients. The opportunity to work with Sooma on their efforts to potentially bring an entirely new type of treatment to the hands of patients with MDD is incredible.”

Sooma 2GEN has been approved for MDD treatment in several European countries, but no device using tDCS therapy has yet received market entry approval in the US for any condition. Positive results from the trial could support clinical validation efforts for Sooma 2GEN in the US.

References

1. Lindus Health and Sooma Medical announce pivotal device clinical trial for treatment of MDD. News release. March 11, 2025. Accessed March 12, 2025. https://www.lindushealth.com/news/lindus-health-and-sooma-medical-announce-pivotal-device-clinical-trial-for-treatment-of-mdd

2. Sooma Medical announces pivotal FDA IDE clinical trial for at-home brain stimulation device for depression treatment. News release. March 11, 2025. Accessed March 13, 2025. https://soomamedical.com/fda-ide-approval-for-sooma/

3. Lookene M, Markov N, Nikander M, et al. Reduction of symptoms in patients with major depressive disorder after transcranial direct current stimulation treatment: a real-world study. Journ. of Affective Disorders Reports. 2022;8:100347.