Lindus begins US trial of transcranial depression treatment device

London, UK-headquartered CRO Lindus Health has been hired to run a clinical trial of a device designed to treat depression developed by Helsinki, Finland-based Sooma Medical.

The Phase III study, which was granted an Investigational Device Exemption (IDE) by the US FDA this month, will evaluate the device, a cap that uses transcranial direct current stimulation (tDCS), as a therapy for major depressive disorder (MDD).

Lindus plans to enroll approximately 200 people from across the US in the study. The CRO will use its eClinical platform to prescreen potential participants and conduct in-home “virtual” study visits.

The device — called Sooma 2GEN — is already approved to treat MDD in several countries across Europe. According to Sooma, positive results from this study will support efforts to obtain US approval.

Michael Young, co-founder of Lindus Health, said, “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, and we can’t wait to hit the ground running.”

Sooma CEO Tuomas Neuvonen said, “We’re excited to partner with Lindus Health to generate US data that will demonstrate Sooma 2GEN’s capabilities in improving the quality of life in depression patients.”

News of the study comes just weeks after Lindus started a trial of a chronic fatigue syndrome therapy in collaboration with the Hamburg, Germany-based Tiefenbacher Group.

Like the Sooma trial, the Tiefenbacher study will use Lindus’ eClinical platform for prescreening, data capture through electronic patient reported outcomes (ePROs), and the organization of virtual visits with the study team.

In addition, the Phase II study — called ReMEdi — requires that participants to wear an Oura ring for continuous remote monitoring and use a GripAble device for hand grip testing to capture data from which will feed into Lindus’ platform.

DepositPhotos/DmitriyDemidovich