Trials Today

TMS-EEG Biomarkers for Chronic Pain

Purpose

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.

Condition

Chronic Pain

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Male and female participants aged 18-80 with a diagnosis of chronic pain agreeing to participate in all study procedures. To maximize accrual and phenotypic variability in the sample for planned analyses, we include patients meeting ICD-11 criteria for chronic pain, a duration-based parent code for several common, clinically relevant pain conditions. Patients must have pain lasting more than 6 months.

Exclusion Criteria

Neurologic disorders: Dementia, Severe neurocognitive disorder (MoCA < 22), Severe aphasia, Seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, neoplasms, hydrocephalus, sequelae of meningitis, MS plaques), cerebral palsy, or complete paralysis - Major psychiatric disorders (e.g., Bipolar Disorder, Schizophrenia), suicidal thoughts - Subjects with any metallic brain implant or fragments (such as shunt, pacemaker, clips, coils, bullet fragments, cochlear implants). - Subjects with any implanted devices activated or controlled by physiological signals and/or ferromagnetic or other magnetic sensitive metals implanted in the head or anywhere within 12 inches/30 cm from the stimulation coil. - Subjects using medications that may alter electroencephalography (EEG) waveforms, including ketamine and benzodiazepines, are eligible to participate, but will be asked to hold these medications 4-8 hours prior to the study visits, as appropriate. - Pregnant or breastfeeding woman.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other Longitudinal TMS-EEG	Each visit will involve completion of the TMS-EEG intervention.	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.

Recruiting Locations

UCSF
San Francisco 5391959, California 5332921 94107

Contact:
Aqsa Khan, MBBS
415-502-5093
aqsa.khan@ucsf.edu

More Details

NCT ID: NCT07116278
Status: Recruiting
Sponsor: University of California, San Francisco

Study Contact

Aqsa Khan, MBBS
415-502-5093
aqsa.khan@ucsf.edu

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.