NCT07116278

TMS-EEG Biomarkers for Chronic Pain

Deriving Candidate Diagnostic and Prognostic Network Biomarkers for Chronic Pain Using the QuantalX DELPHI TMS-EEG System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators aim to assess the correlates of neurophysiological measures (measurement of brain magnetically evoked response) using DELPHI system. The DELPHI system device is a computerized, electromechanical medical device that produces and delivers non-invasive Transcranial Magnetic Stimulation (TMS) fields to induce electrical currents directed at regions of the cerebral cortex and records the resultant Electroencephalogram (EEG) brain electrophysiological response. DELPHI analyzes the TMS Evoked Potential (TEP) and produces quantitative output measures. Objectives include: * To use TMS-evoked EEG measures of brain function in patients with chronic pain using the QuantalX DELPHI system to predict patient specific pain diagnoses using machine learning classification methods. * To evaluate longitudinal associations between TMS-evoked EEG measures and ratings of chronic pain. * To monitor associations between TMS-evoked EEG biomarkers and therapy success for three different classes of medications.

Detailed description

Chronic pain is the leading cause of disability worldwide. Patients with chronic pain have highly variable responses to available treatments, leading to trial-and-error based interventions that delay relief, prolong suffering, and increase reliance on potentially addictive opioid analgesics. This hallmark variability between individual patients is a key barrier to the development of reliable biomarkers for diagnosis and treatment selection. Chronic pain is associated with maladaptive reorganization of brain circuits involved in sensory, emotional, and cognitive aspects of pain. However, specific abnormalities and their relationships to personalized outcomes are unknown. Here, the investigators propose to collect measures of brain network connectivity, excitability, and plasticity using the QuantalX DELPHI-MD (TMS-EEG) system to identify mechanistic biomarkers for patient diagnosis and treatment prognosis. This is a prospective, pilot cohort study. Relationships uncovered during analysis of pilot data will be used to support future experimental research and better characterize specific measures that may be useful to collect in ongoing patient outcome research at UCSF.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	QuantalX DELPHI-MD (TMS-EEG)	Direct Electro-Physiological Imaging medical device (DELPHI-MD), developed by QuantalX Neuroscience, is a neurophysiological assessment system which utilizes a specific TMS-EEG protocol that automatically analyzes specific features of this brain response to reproduce numerical output measures. DELPHI-MD has previously shown to differentiate different healthy age groups, mild dementia and Parkinson's Disease (PD) from age matched healthy control. In addition, DELPHI-MD measures are correlated to white matter microstructural differences in post stroke and TBI patients. This multimodal approach allows for the evaluation of several neurophysiological mechanisms such as cortical reactivity, excitation and inhibition in local and distal regions, effective connectivity, and neural plasticity, characterized as modifications that outlast the stimulation period. The investigators predict that Delphi-MD has the potential to identify features of brain function altered in pain syndromes.

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-08-11
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study