DARPA SPARC-TMS Trial

Clinical Evidence. Rigorously Earned.

NRx is conducting clinical research under DARPA's Surmounting Obstacles in PTSD (SPARC) program — applying fMRI-guided, robotically controlled TMS to the most treatment-resistant cases of PTSD and depression in the warfighter population.

Trial Overview

The SPARC-TMS Trial

The SPARC-TMS trial is a DARPA-contracted clinical study evaluating the NRx platform — fMRI-guided neuronavigation combined with robotically controlled TMS and FDA-investigational neuroplastic medication — in active duty military personnel and veterans with treatment-resistant PTSD and major depressive disorder.

TMS works by driving the creation of new synapses in the brain. The SPARC-TMS trial tests whether fMRI-guided targeting of the precise brain centers malfunctioning in each patient's PTSD or depression, combined with FDA-investigational neuroplastic medications that have the potential to enhance that synaptogenic effect, produces superior outcomes to conventional TMS protocols.

The trial is registered on ClinicalTrials.gov. For the most current protocol information, recruitment status, and study center locations, refer to the official trial record.

Official Registry

The SPARC-TMS trial is registered on ClinicalTrials.gov, the official U.S. registry of clinical studies maintained by the National Library of Medicine. The registry record contains the authoritative protocol, eligibility criteria, study center locations, and current recruitment status.

View Trial Record on ClinicalTrials.gov

Selected as Prime Contractor (currently in contracting) by

Defense Advanced Research Projects Agency (DARPA)

Surmounting Obstacles in PTSD (SPARC) Program

Study Protocol

How the Trial Works

The SPARC-TMS trial protocol applies the full NRx platform in a structured clinical research setting, with rigorous outcome measurement at each stage.

Step 01

Screening & Eligibility

Participants are evaluated for diagnosis of PTSD and/or major depressive disorder, prior treatment history, and eligibility criteria. The trial focuses on treatment-resistant cases — participants who have not achieved adequate response to conventional treatments.

Step 02

Functional MRI Brain Mapping

Each enrolled participant undergoes functional MRI imaging to identify the precise brain centers malfunctioning in their individual presentation of PTSD or depression. This produces a patient-specific neural targeting map for all subsequent TMS sessions.

Step 03

Neuroplastic Medication Protocol

FDA-investigational neuroplastic medications are administered alongside TMS sessions. These compounds have the potential to enhance the synaptogenic effect of TMS — amplifying the brain's capacity to form new synaptic connections in the fMRI-identified target circuits.

Step 04

Robotically Controlled TMS Sessions

The robotic TMS system delivers precisely targeted stimulation to the brain centers identified by fMRI — with sub-millimeter accuracy and session-to-session reproducibility. The number and frequency of sessions follows the trial protocol.

Step 05

Outcome Assessment

Standardized clinical outcome measures are administered at defined intervals throughout the trial. Assessments include validated PTSD and depression rating scales, functional status measures, and neuroimaging follow-up to quantify synaptogenic response.

Step 06

Follow-Up & Durability

Participants are followed after the active treatment phase to assess the durability of synaptogenic response and clinical outcomes — providing evidence on the long-term impact of the NRx protocol on warfighter mental health and operational readiness.

Who May Qualify

Eligibility Overview

Eligibility criteria are defined in the official trial protocol. The following represents a general overview — the ClinicalTrials.gov record is the authoritative source for inclusion and exclusion criteria.

May be eligible if
  • Active duty military personnel or veterans
  • Diagnosis of PTSD and/or major depressive disorder
  • Treatment-resistant presentation — inadequate response to prior treatment
  • Adults 18 years of age or older
  • Able to provide informed consent and complete the study protocol
General exclusions include
  • Active psychosis or bipolar I disorder
  • Implanted metal devices incompatible with MRI or TMS
  • History of seizure disorder
  • Pregnancy
  • Other conditions as specified in the full protocol
Trial Enrollment

Inquire About Participation

If you or someone you know may be eligible for the SPARC-TMS trial, submit an inquiry below. A member of the NRx clinical team will respond to discuss eligibility, study center locations, and next steps.

Submitting this form does not enroll you in the trial. Enrollment requires a formal screening evaluation conducted by the study team at a participating site. All information submitted is confidential.