TMS-EEG for Chronic Pain

(DELPHI TMS-EEG Trial)

Overseen By Aqsa Khan, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Neurologic disorders, Major psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how brain activity responds to magnetic stimulation in people with chronic pain. The goal is to use these brain responses to better understand a patient's specific pain condition and their reaction to different pain medications. This understanding could help doctors predict the best treatment options for individuals. The trial seeks participants who have experienced pain for more than six months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to more personalized pain management strategies.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that can affect brain wave measurements, like ketamine and benzodiazepines, for 4-8 hours before study visits. For other medications, the trial protocol does not specify any requirements.

What prior data suggests that the DELPHI system device is safe for use in chronic pain patients?

Research has shown that the QuantalX DELPHI-MD device received FDA approval for safely stimulating nerves, indicating its safety for use in people. It has also been recognized as a breakthrough for its innovative approach to brain health.

In other studies, the DELPHI-MD device caused side effects that were generally mild and manageable for individuals with chronic pain. This suggests safety, though individual experiences may vary. Participants should consult trial coordinators or healthcare providers with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TMS-EEG technique for chronic pain because it offers a novel approach to managing this condition. Unlike traditional treatments that often rely on medications like opioids or NSAIDs, TMS-EEG combines transcranial magnetic stimulation with electroencephalography to potentially modulate brain activity directly related to pain perception. This method could provide a non-invasive alternative that targets the neural pathways of pain, possibly reducing reliance on drugs and minimizing side effects. Additionally, the longitudinal application of this technique allows researchers to assess changes over time, providing insights into its long-term effectiveness and safety.

What evidence suggests that the DELPHI system is effective for chronic pain?

Research has shown that the QuantalX DELPHI-MD system, which combines Transcranial Magnetic Stimulation (TMS) with an Electroencephalogram (EEG), might help treat chronic pain by altering brain connectivity and function. TMS sends magnetic pulses to specific brain areas to stimulate them, while the DELPHI system monitors the brain's response. This system identifies patterns in brain activity associated with chronic pain, using these patterns to predict and potentially enhance pain management. Some studies suggest this method could aid in earlier diagnosis and effectively manage chronic pain, with manageable side effects. Although data from human studies remain limited, this approach shows promise in understanding and treating chronic pain. Participants in this trial will receive the TMS-EEG intervention to further evaluate its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Julian Motzkin, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals suffering from chronic pain, including persistent pain after surgery. Participants should be suitable candidates for non-invasive brain stimulation and EEG recording. Specific eligibility criteria are not provided but typically include age, health status, and the nature of the chronic pain condition.

Inclusion Criteria

I have been diagnosed with chronic pain according to ICD-11 standards.

I am between 18 and 80 years old and have chronic pain.

I have been experiencing pain for more than 6 months.

Exclusion Criteria

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

I can stop taking certain medications like ketamine or benzodiazepines before study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment using TMS-EEG intervention and baseline questionnaires

1 day

1 visit (in-person)

Longitudinal TMS-EEG Intervention

Participants undergo TMS-EEG intervention and complete various questionnaires over multiple visits

9-12 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• QuantalX DELPHI-MD

Trial Overview The study tests a device called QuantalX DELPHI-MD that uses Transcranial Magnetic Stimulation (TMS) to stimulate the brain and records responses with an EEG. It aims to predict pain diagnoses, track changes in chronic pain over time, and assess how well different medications work using TMS-EEG biomarkers.

How Is the Trial Designed?

Group I: Longitudinal TMS-EEG Experimental Treatment 1 Intervention

Each visit will involve completion of the TMS-EEG intervention.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116278

NCT07116278 | TMS-EEG Biomarkers for Chronic Pain Here, the investigators propose to collect measures of brain network connectivity, excitability, and plasticity using the QuantalX DELPHI-MD (TMS-EEG) system to ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07116278

TMS-EEG Biomarkers for Chronic Pain Here, the investigators propose to collect measures of brain network connectivity, excitability, and plasticity using the QuantalX DELPHI-MD ( ...

3. trialstoday.org trialstoday.org/trial/NCT07116278

TMS-EEG Biomarkers for Chronic Pain DELPHI analyzes the TMS Evoked Potential (TEP) and produces quantitative output measures. Objectives include: - To use TMS-evoked EEG measures of brain function ...

4. withpower.com withpower.com/trial/phase-chronic-pain-10-2024-c4ec1

TMS-EEG for Chronic Pain ... QuantalX DELPHI-MD will have tolerable side effects & efficacy for patients with Chronic Pain, Chronic Persistent Surgical Pain and Chronic Pain. See if you ...

5. neurologylive.com neurologylive.com/view/fda-clears-quantalx-neuroscience-delphi-stimulator-direct-brain-health-diagnosis

FDA Clears QuantalX Neuroscience's Delphi Stimulator for ... Delphi-MD uses high-resolution magnetic pulses to detect brain abnormalities, aiding early diagnosis of conditions like stroke, dementia, and ...

6. trialx.com trialx.com/clinical-trials/listings/324567/tms-eeg-biomarkers-for-chronic-pain/

TMS-EEG Biomarkers for Chronic Pain To use TMS-evoked EEG measures of brain function in patients with chronic pain using the QuantalX DELPHI system to predict patient specific pain ...

7. quantalx.com quantalx.com/delphi-research/

Delphi Research The Delphi-MD device was granted the prestigious FDA breakthrough designation technology status, providing early detection and differential diagnosis of stroke ...