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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longitudinal TMS-EEG | Other | Each visit will involve completion of the TMS-EEG intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuantalX DELPHI-MD (TMS-EEG) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TMS-Evoked Potential Amplitude | The QuantalX DELPHI (TMS-EEG) system will be used to generate N45 potential amplitudes from the primary motor cortex. The DELPHI System is used for acquisition of physiological signals of Electroencephalography (EEG) from the scalp in response to magnetic stimulation. It consists of a DELPHI amplifier, a computer (workstation), a patient EEG cap, a transcranial magnetic stimulation (TMS) device and "Figure 8" stimulation coil. To limit the effect of medications on EEG results, participants will be asked to hold medications known to significantly alter EEG waveforms (including ketamine and benzodiazepines) 4-8 hours prior to the study visits, as appropriate. The device can also generate a range of regional and global metrics of brain excitability (e.g., N100 potential amplitudes), plasticity (e.g., change in N45 amplitude after conditioning pulses), and connectivity (e.g., between region coherence) at each scheduled clinic visit. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Visual analog scores (VAS) | Real time pain intensity and unpleasantness ratings from 0 to 100. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scales (NRS) | Real time pain intensity and unpleasantness ratings from 1 to 10. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Pain Body Maps |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal Pain Detection Threshold | Cold pain and heat pain (°C) thresholds are assessed using Quantitative Sensory Testing (QST) . | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Motzkin, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31551761 | Background | Zifman N, Levy-Lamdan O, Suzin G, Efrati S, Tanne D, Fogel H, Dolev I. Introducing a Novel Approach for Evaluation and Monitoring of Brain Health Across Life Span Using Direct Non-invasive Brain Network Electrophysiology. Front Aging Neurosci. 2019 Sep 9;11:248. doi: 10.3389/fnagi.2019.00248. eCollection 2019. | |
| 34216938 | Background |
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We will share de-identified TMS-EEG data with our industry collaborators. We will share de-identified TMS-EEG, QST, and self-reported pain data via open science repositories.
All data will be deposited to OpenNeuro and OSF within 6 months of the final publication resulting from these data.
To request access of the data, researchers will use the standard processes at OSF, which involve contacting the study author for use permission. Data can be accessed freely on UCSF MyResearch.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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|
A validated visual representation of the human body allowing patients to record the location and severity of pain.
| Visit 1(Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| NIH PROMIS questionnaires | The NIH PROMIS toolbox contains a host of survey questions tailored to measurement of specific disease states such as pain, global health and function. We will specifically use the Global Health, nociceptive and neuropathic pain (short forms), pain interference (short form), and Patient global impression of change. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| McGill Pain Questionnaire (MPQ) | The McGill Pain Questionnaire is a validated measure of multiple domains of pain processing, including sensory and affective pain processing as well as nociceptive and neuropathic pain. Scores range from 0-45 with higher scores indicating more pain. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Pain Catastrophizing Scale (PCS) | Validated scale measuring emotional responses to pain to track pain-related symptoms. Scores range from 0-52 with higher scores indicating higher pain catastrophizing. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Beck Depression Inventory-II (BDI-II) | Validated measure of clinical depression symptoms to quantify and track mood over time. Scores range from 0-63 with higher scores indicating more depression. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| World Health Organization Disability Assessment Schedule (WHODAS) | Assessment of functional disability from the WHO to track level of function over time. Scores range from 0-100 with higher scores indicating more disability. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Pittsburgh Sleep Quality Index (PSQI) | Validated scale that measures sleep and insomnia symptoms. Scores range from 0-21 with higher scores indicating worse sleep quality. | Visit 1 (Baseline), Visit 2 (1-3 months after the first visit), Visit 3 (3-6 months), Visit 4 (6-9 months), Visit 5 (9-12 months) |
| Maidan I, Zifman N, Hausdorff JM, Giladi N, Levy-Lamdan O, Mirelman A. A multimodal approach using TMS and EEG reveals neurophysiological changes in Parkinson's disease. Parkinsonism Relat Disord. 2021 Aug;89:28-33. doi: 10.1016/j.parkreldis.2021.06.018. Epub 2021 Jun 29. |
| 33408607 | Background | Levy-Lamdan O, Zifman N, Sasson E, Efrati S, Hack DC, Tanne D, Dolev I, Fogel H. Evaluation of White Matter Integrity Utilizing the DELPHI (TMS-EEG) System. Front Neurosci. 2020 Dec 21;14:589107. doi: 10.3389/fnins.2020.589107. eCollection 2020. |
| 34526957 | Background | Fogel H, Levy-Lamdan O, Zifman N, Hiller T, Efrati S, Suzin G, Hack DC, Dolev I, Tanne D. Brain Network Integrity Changes in Subjective Cognitive Decline: A Possible Physiological Biomarker of Dementia. Front Neurol. 2021 Aug 30;12:699014. doi: 10.3389/fneur.2021.699014. eCollection 2021. |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |