- Dr. Darin Dougherty, Chief Medical Officer
Interim 36-Month Outcomes from Inner Cosmos’ Psychiatric Neurostimulation Study in Treatment-Resistant Depression
Inner Cosmos is pleased to share new interim data from our ongoing three patient clinical trial evaluating the safety and feasibility of our minimally invasive neurostimulatory device for treatment-resistant depression as part of our FDA-approved early safety and feasibility study. While safety and feasibility are the primary outcomes for this initial trial, we are also collecting efficacy data.
Our goal is to demonstrate that the Inner Cosmos device will provide benefits equal to or better than Transcranial Magnetic Stimulation (TMS) in a mobile form factor that does not require repeated visits to the clinic.
While we have previously reported on accomplishing this goal in our first two patients, this update marks the first time we are publicly sharing results from our third patient, who has now been classified as a clinical responder. They have achieved a 54% improvement in depressive symptoms from baseline, representing a 21% gain over their best prior TMS outcome.
This milestone highlights continued momentum in the trial and reinforces the therapeutic potential of Inner Cosmos’ psychiatric brain-computer interface.
Study Overview
The ongoing clinical study includes adult participants diagnosed with treatment-resistant depression (TRD), defined as an inadequate response to at least two classes of antidepressant therapies.
The need for such innovation is urgent. Over 70,000 new TMS-treated patients are added annually in the United States, and more than 35,000 patients relapse after initially responding to existing treatments. Moreover the 70,000 patients treated with TMS in the US represent only one percent of patients with TRD, owing to access and compliance issues. Additionally, those who respond experience a 90% drop-off from treatment to retreatment, due to the compliance demands of multiple extended clinic visits. Our goal is to deliver TMS-like therapy that can be delivered in the home environment.
Inner Cosmos aims to deliver a safe, mobile (at-home), minimally invasive alternative for patients who have exhausted traditional therapeutic options. This approach will markedly increase compliance and access for patients in need.
Interim Results
No serious adverse events (SAEs) or safety issues have been observed to date on any of the patients.
We have now reported clinical outcomes from three patients:
- Patient 1: With Inner Cosmos, the patient achieved a 41% improvement in depressive symptoms from baseline, representing a 27% gain over their best prior TMS outcome.
- Patient 2: Over 17 months of continuous therapy, Patient 2 achieved an 83% improvement from baseline with Inner Cosmos, representing a 60% gain over their best prior TMS outcome. This patient has remained in the remission range for over a year despite significant life stressors. Given the strong and sustained therapeutic benefit, the patient elected to continue long-term use.
- Patient 3: After seven (of twelve) months of therapy, Patient 3 has recorded a 54% reduction in depressive symptoms from baseline, representing a 21% gain over their best prior TMS outcome. This patient is currently classified as a clinical responder to the Inner Cosmos treatment.
Improvements in mood, motivation, and daily functioning have been documented through structured assessments and independently confirmed by family reports. Treatment continues under close observation.
Next Steps
The clinical study is ongoing and outcomes will continue to be reported at regular intervals and submitted for peer-reviewed publication upon study completion.
These interim findings demonstrate meaningful, sustained symptom improvement in patients with long-standing treatment resistance, over the course of a total of 36 patient months. All three patients treated to date have surpassed their previous best TMS outcomes, reinforcing the potential of Inner Cosmos’ psychiatric brain-computer interface to transform care in this field.
We remain committed to transparency in our development process and are deeply grateful to the patients and families participating in this important clinical research.
Dr. Darin Dougherty
Chief Medical Officer
Inner Cosmos
Dr. Darin Dougherty is the Co-Founder and Chief Medical Officer of Inner Cosmos, a neurotechnology company pioneering minimally invasive brain-computer interfaces to treat depression and other cognitive disorders. A leading figure in neuropsychiatry, Dr. Dougherty also serves as Director of the Neurotherapeutics Division in the Department of Psychiatry at Massachusetts General Hospital (MGH) and as an Associate Professor of Psychiatry at Harvard Medical School.
With over two decades of experience, Dr. Dougherty has led numerous clinical trials and research initiatives focused on neuromodulation therapies, including deep brain stimulation (DBS) and transcranial magnetic stimulation (TMS), for treatment-resistant psychiatric conditions such as major depressive disorder, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). His work has been instrumental in advancing the understanding and application of neurotherapeutic interventions in psychiatry.
About Inner Cosmos: Pioneering the field of Psychiatric BCI
Inner Cosmos is advancing psychiatric care by creating a minimally invasive, neurotechnology device that is embedded in the top of the skull to transmit neurostimulation that can treat cognitive disorders and mental health diseases like depression. Similar to how a pacemaker sits on top of the heart, Inner Cosmos has created a TMS to-go treatment that provides neurostimulation from the comfort of a patient’s home, while Psychiatrists can monitor their patients remotely and update treatments wirelessly to the implanted device.
While most brain-computer interface systems to date have focused on restoring physical or sensory function, Inner Cosmos is pioneering a new use case for BCI/psychiatric intervention. This category targets dysfunction within large-scale brain networks responsible for emotional regulation, attention, and cognitive flexibility.