What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS) has shown promise in alleviating pain and associated symptoms. Known side effects of TMS are generally mild and may include headaches, scalp discomfort at the stimulation site, and, rarely, brief episodes of lightheadedness. Serious adverse events are uncommon. Other treatments for CRPS, such as repetitive transcranial magnetic stimulation (rTMS), have similar side effects, including transient discomfort and rare instances of seizures, particularly in patients with a predisposition to epilepsy.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of Complex Regional Pain Syndrome (CRPS) using Transcranial Magnetic Stimulation (TMS) or similar neuromodulatory treatments in the provided context. However, TMS is being studied for its efficacy in treating CRPS by modulating neural activity to alleviate pain and associated symptoms. Other treatments for CRPS typically include medications, physical therapy, and nerve blocks, but these are not directly related to TMS.

What other types of research exist?

Promising novel alternatives to TMS for CRPS patients include Spinal Cord Stimulation (SCS) and Scrambler Therapy. SCS has been shown to be effective in treating chronic pain by modulating neural activity in the spinal cord. Scrambler Therapy, which uses electrical stimulation to provide pain relief, has also demonstrated efficacy in treating chronic pain conditions, including cancer-related pain, and may be applicable to CRPS.

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Non-invasive Brain Stimulation

TMS for Complex Regional Pain Syndrome

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average pain level reported on Numerical Rating Scale meets entry criteria

Age 18-70

Must not have

Neurologic illness that would interfere with brain integrity

History of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration from last treatment until pain returns - up to an estimate of 6 months

Summary

This trial is testing a new method that uses magnetic pulses to influence brain activity. It aims to help people with a difficult-to-treat chronic pain condition by reducing pain and improving symptoms. This method has been used in various conditions, including depression, Parkinson's disease, Alzheimer's disease, and chronic pain.

Who is the study for?

This trial is for adults aged 18-70 with Complex Regional Pain Syndrome (CRPS) for at least 3 months, who can perform required tasks and have a certain level of pain. It's not for those with psychological disorders, medical conditions or medications that affect the study, pregnant women, people in legal/disability claims, TMS contraindications like metal implants near stimulation site, epilepsy sufferers or those with MRI contraindications.

What is being tested?

The trial tests if Transcranial Magnetic Stimulation (TMS) can reduce CRPS-related pain and improve cognitive, emotional and physical symptoms. Participants are divided into two groups: one receives TMS while the other gets sham treatment daily for two days. Their progress is monitored until they return to baseline pain levels for two weeks.

What are the potential side effects?

While specific side effects of TMS in this trial aren't listed, common ones include discomfort at the stimulation site during treatment sessions, headache after treatment and rarely seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level matches the study's required range.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any brain conditions that affect its function.

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I have a history of epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration from last treatment until pain returns - up to an estimate of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration from last treatment until pain returns - up to an estimate of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration from last treatment until pain returns - up to an estimate of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain

Duration of Pain Relief

Secondary study objectives

Change in Pain-related Symptomology

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 Intervention

Participants will receive active TMS in the target area once daily for two days

Group II: Sham TreatmentPlacebo Group1 Intervention

Participants will receive active TMS in a non-target area once daily for two days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation (TMS)

2018

Completed Phase 4

~550

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) and other neuromodulation techniques, such as spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS), are commonly used to treat Complex Regional Pain Syndrome (CRPS). These treatments work by modulating neural activity to reduce pain and improve associated symptoms like cognitive and emotional disturbances. TMS uses magnetic fields to stimulate nerve cells in the brain, which can alter pain perception and improve mood. SCS involves the implantation of a device that sends electrical impulses to the spinal cord, disrupting pain signals before they reach the brain. TENS delivers electrical currents through the skin to stimulate nerves and reduce pain. These mechanisms are crucial for CRPS patients as they offer non-pharmacologic options to manage chronic pain and improve quality of life.