RecruitingNAINTERVENTIONAL

Protocol Assessment of Motor Cortex rTMS for Treating Neuropathic Pain

If you suffer from long-lasting pain caused by nerve damage, and medicines haven't fully helped, this study might be for you. It's investigating a treatment called transcranial magnetic stimulation (TMS), which uses magnetic pulses to stimulate the brain. We're comparing three different ways of giving TMS to see which is most effective at reducing pain. We also want to find out which method is most convenient for patients. The goal is to discover if a new, faster TMS method could offer better pain relief for more people. The study will involve assessing pain levels and daily activities over several weeks.

At a glance

Status

Recruiting

Phase

Sponsor

Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)

Enrolment target

Start

01 Apr 2025

Estimated completion

01 Feb 2027

Chronic Pain Syndrome Peripheral Neuropathic Pain

What is this study about?

This study is about a type of treatment called transcranial magnetic stimulation, or TMS. It's for people who have long-lasting pain caused by nerve damage, a condition known as neuropathic pain. Many people with this type of pain don't get enough relief from medicines. TMS works by using magnetic pulses to gently stimulate specific areas of the brain, and it's already used for some conditions like depression and chronic pain.

The main idea behind this study is to compare three different ways of giving TMS treatment. One way involves daily sessions for a week or two, followed by weekly top-ups. Another method spaces out the sessions more, over several days or weeks. The third, newer method, usually used for depression, involves more short sessions grouped together over just a few days. We don't yet know if this newer, quicker method is good for nerve pain, or how it compares to the other two for pain relief.

By comparing these three methods, we hope to understand which one gives the best pain relief and which is the most practical for people to fit into their lives. For example, some methods involve more total stimulation, while others involve fewer days of treatment. This research could help doctors decide the best way to use TMS to ease chronic nerve pain for more patients in the future.

Key takeaways

New study compares different TMS methods for long-lasting nerve pain.
Aims to find the most effective and convenient TMS treatment plan.
Involves magnetic stimulation of the brain, not surgery or injections.
Participants will be randomly assigned to one of three treatment groups.
Requires keeping a pain diary for about 13 weeks.
Could help improve future pain management for nerve pain sufferers.

Who may be eligible?

To join this study, you need to be between 18 and 80 years old and have been experiencing long-lasting pain from nerve damage for at least six months. This pain should be clearly linked to your nerve condition and be at a level of 4 out of 10 or higher. You'll also need to be able to sign a form saying you understand what the study involves and agree to take part, and be a member of the social security system.

There are also some reasons why you might not be able to join. These include certain other health conditions, such as some brain disorders like epilepsy or a history of stroke, or specific mental health conditions. You also can't take part if you have any metal objects in your head (like certain medical implants) that could interfere with the TMS treatment, or if you have epilepsy that isn't well controlled by medication.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Have you had chronic nerve pain for at least 6 months?
Is your average daily pain level 4 out of 10 or higher?
Do you have a clear diagnosis of peripheral neuropathy?
Do you have any metal implants in your head or active epilepsy?
Are you able to provide signed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a routine medical visit where the study will be fully explained. You'll get information to read at home and then have at least a week to think about it. If you decide to go ahead, you'll have an inclusion visit to check if you meet all the requirements and to sign a consent form.

Next, you'll be randomly assigned to one of three different TMS treatment groups. This is like drawing names from a hat, so neither you nor the researchers can choose which group you're in. All treatments will use the same kind of brain stimulation, but differ in how many sessions you have and how often. You'll have TMS treatment sessions at the Henri Mondor University Hospital in Créteil, France. On some of your treatment days, you might have more than one session. For example, some treatment plans could involve sessions over 10 days, while others might group them into just 4 days.

Throughout the study, you'll be asked to keep a pain diary for 13 weeks. In this diary, you'll note your daily pain levels (from 0 to 10), how many pain 'attacks' you have, and any extra pain medication you take. Information about your age, gender, medical history, and current medications will also be collected at the start of the study. There will be no specific medication given as part of the study; you will continue with your usual treatments. The total duration of active participation including Diaries would be around 3 months maximum.

Potential risks and benefits

Taking part in this study could potentially help you understand more about your condition and may lead to a reduction in your chronic nerve pain, though this is not guaranteed. Researchers will learn more about the most effective and convenient ways to use TMS for nerve pain, which could benefit many people in the future. As with any medical procedure, there are potential risks with TMS, though it is generally considered safe. Common side effects can include mild headaches or scalp discomfort, which usually go away soon after treatment. There's a very rare risk of seizures, but staff will be trained to manage this. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Henri Mondor University Hospital
Verified postcode
Créteil, France· Recruiting

Common questions

What is TMS?

TMS stands for transcranial magnetic stimulation. It's a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, often to improve symptoms of certain conditions like chronic pain.

What kind of pain is this study for?

This study is for people with chronic neuropathic pain, which is long-lasting pain caused by damage to nerves.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of three different TMS treatment plans. Neither you nor the researchers will choose your group, to keep the study fair.

How long will I need to be in the study?

Your active participation, including treatment sessions and keeping a pain diary, will be around three months in total. The treatment itself will take place over a shorter period within that timeframe.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Jean-Pascal Lefaucheur, MD, PhD

jean-pascal.lefaucheur@aphp.fr 800-555-5555 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.