Pulvinar Neuro LLC

Xcsite 300: Cloud-enabled Closed-loop Transcranial Current Stimulation Device for At-home Studies - Project Summary – Pulvinar Neuro LLC, Townsend the Causal Role of Circuit Activity Dynamics in Depression Remains Poorly Understood Due to the Lack of Tools for Non-invasive, Targeted Circuit Modulation. Today’s Non-invasive Brain Stimulation Approaches Apply Generic Stimulation Waveforms Without Targeting Individual Activity Signatures and Without Dynamically Adapting Stimulation to Ongoing Fluctuations in Brain Activity. to Address This Gap, the Long-term Goal of Pulvinar Neuro Is to Develop, Evaluate, and Commercialize Targeted Closed-loop Transcranial Alternating Current Stimulation (TACS) Technology, Which Measures Brain Activity With Eeg and Dynamically Applies Weak Rhythmic Electric Fields to Modulate Network Oscillations. in the Previous Phase 1 Sbir, Pulvinar Neuro Developed Xcsite 100PRO, a Closed-loop Tacs Device That Was Successfully Tested for Feasibility in Healthy Human Participants, and Xcsite 200, a Cloud-based Platform for Remote Stimulation. the Overall Goal of This Application Is to Develop and Evaluate the Xcsite 300 Platform That Will Integrate Closed-loop Capabilities With Cloud-based Stimulation and Study Management. the Rationale for This Project Is That Such a Solution Will Drive the Next Generation of Circuit-based Research in Psychiatry and That Closed-loop Tacs Has the Potential to Become a Safe and Effective Treatment for Depression Given the Initial Positive Findings of Open-loop Tacs for the Treatment of Depression and the Substantial Unmet Market Need. Three Specific Aims Will Be Pursued to Accomplish This Goal. (1) Integrate and Bench Test Closed-loop Tacs Technology With Cloud-based Infrastructure, (2) Test Xcsite 300 for In-lab Use in a Pilot Double-blind Single-site Study for the Treatment of Depression (xcsite 300 Clinic), and (3) Adapt Device Form Factor and User Interface for At-home Use (xcsite 300 Home) and Establish Feasibility in a Pilot Study in People With Depression. at Completion of the Proposed Work, Feasibility and Preliminary Efficacy of Closed-loop Tacs Will Be Established and Closed-loop Tacs for Use in a Clinic and for At-home Use by Patients Will Be Ready for Pivotal Studies for the Treatment of Depression. the Work in This Application Is Innovative Given the Lack of Available Cloud-enabled (“smart”) Closed-loop Tacs Devices for Probing Circuit Dynamics and for Evaluation of Clinical Efficacy in Rigorous Double-blind Trials. the Proposed Work Is Significant Since Closed-loop Tacs Will Enable the Investigation of the Causal Role of Specific Circuit Dynamics in Humans and the Development of Novel Treatments for Depression Which Are Urgently Needed.