Cooperative Agreement UG3DE036325

The National Institute of Dental and Craniofacial Research awarded a cooperative agreement of $571,544 to The Regents of the University of California, San Francisco on September 1, 2026, under the Oral Diseases and Disorders Research program (CFDA 93.121) to conduct a pivotal Phase III multi-site clinical trial of high-frequency repetitive transcranial magnetic stimulation at the primary motor cortex for trigeminal neuropathic pain.

The trial evaluates the safety, efficacy, and durability of 10-Hz high-frequency repetitive transcranial magnetic stimulation targeting the motor cortex opposite pain in patients with trigeminal neuropathic pain, a treatment-resistant chronic pain condition caused by lesion or disease affecting the trigeminal nerve or its central pathways. The study employs an FDA-aligned, double-blind, randomized design and builds on pilot data demonstrating feasibility, safety, and robust short-term efficacy. A key objective is establishing that the treatment produces durable, clinically meaningful benefit lasting several months—a durability milestone required for US regulatory approval. The protocol incorporates refined stimulation parameters, assessment methods, and statistical procedures and assembles a consortium of experienced trial sites with preliminary positive feedback from the FDA supporting the pivotal study design.

Performance occurs at UCSF in San Francisco, California, with a period of performance from September 1, 2026 through August 31, 2027.