RecruitingNAINTERVENTIONAL

Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

This study is investigating new ways to manage chronic neuropathic pain, which is ongoing nerve pain that hasn't improved with typical treatments. Researchers want to compare two different kinds of brain stimulation, called repetitive Transcranial Magnetic Stimulation (rTMS), with a 'dummy' version of the treatment. The goal is to see if either of the active rTMS methods can effectively reduce pain. If you take part, you'll have brain stimulation sessions for seven weeks and keep a daily pain diary. This research aims to understand if rTMS could be a helpful option for people living with persistent nerve pain.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

16 Jul 2021

Estimated completion

01 Dec 2025

Chronic Neuropathic Pain

What is this study about?

Imagine you have ongoing nerve pain that just won't go away, even after trying different treatments. This study is exploring a gentle, non-invasive treatment called repetitive Transcranial Magnetic Stimulation (rTMS) to see if it can help reduce this type of pain. rTMS uses magnetic pulses to stimulate specific areas of the brain that are involved in how we feel pain.

The researchers want to compare two slightly different ways of giving rTMS to a 'sham' treatment. A sham treatment feels similar to the real one but doesn't deliver the actual magnetic pulses. This comparison helps the researchers figure out if any pain relief is truly due to the active rTMS or if it's partly due to other factors, like the expectation of feeling better.

By taking part, you would help doctors understand if rTMS could become a useful new option for people living with chronic neuropathic pain. This is important because it could lead to more effective ways to manage pain for those who haven't found relief with current methods.

Key takeaways

It's about finding new ways to treat long-lasting nerve pain.
Compares two types of brain stimulation (rTMS) with a dummy treatment.
Involves weekly brain stimulation sessions and daily pain diaries.
Participation lasts about 10 weeks.
Aims to help people whose pain hasn't gotten better with other treatments.

Who may be eligible?

To join this study, you must be between 18 and 80 years old and have been experiencing ongoing nerve pain (neuropathic pain) for more than a year. This pain should be on one side of your body, like an arm, leg, face, or half of your body, and haven't gotten better with standard treatments. Also, any pain medications you're currently taking should have been stable for at least a month.

However, some things would mean you can't join. For example, if you have a history of drug addiction, epilepsy, head injury, or certain mental health conditions, you wouldn't be able to participate. You also can't have any metal objects inside your head (like certain implants), or if you've already had rTMS treatment before. Pregnant or breastfeeding women are also unable to join, as are individuals who have recently started new pain treatments within the last month.

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 on one side of your body for over a year?
Has your pain not improved with other common treatments?
Has your pain medication dosage been steady for at least a month?
Do you not have any metal implants in your head or a history of epilepsy?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first have a meeting where everything is explained, and you'll give your written permission. Afterwards, you'll be randomly assigned to one of three groups: two groups will receive different types of active rTMS, and one group will receive the 'sham' (dummy) treatment. Neither you nor the doctors treating you will know which group you're in.

Before treatment starts, you'll keep a simple daily diary for one week, noting your pain levels. After this, you'll begin having brain stimulation sessions over seven weeks. Throughout these seven weeks, and for another two weeks after your last session, you'll continue to record your daily pain levels in your diary. The total time you'll be involved in the study is about 10 weeks.

Potential risks and benefits

By taking part, you might benefit from a reduction in your chronic neuropathic pain, especially if you receive one of the active rTMS treatments. Even if you receive the sham treatment, some people report feeling better due to what’s called a 'placebo effect'. While rTMS is generally safe, potential risks are usually mild and temporary, such as a headache or tingling sensation during treatment. More serious side effects are very rare. Remember, your participation is completely voluntary, and you are free to leave the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Centre de la douleur, CHU Grenoble Alpes
Verified postcode
Grenoble, France· Recruiting

Common questions

What is rTMS?

rTMS stands for repetitive Transcranial Magnetic Stimulation. It's a non-invasive treatment that uses magnetic pulses to gently stimulate specific areas of your brain.

Will I know if I'm getting the real treatment or the dummy treatment?

No, you won't know. The study is designed so that neither you nor the doctor giving the treatment knows which type of stimulation you are receiving, which helps make the results fairer.

How long does the study last?

Your involvement in the study will be for about 10 weeks in total. This includes one week of pain tracking, seven weeks of treatment sessions, and two weeks of follow-up.

What kind of pain is this study for?

This study is for people with chronic neuropathic pain, which is long-lasting nerve pain that hasn't responded well to other treatments.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, and it won't affect your ongoing medical care.

How to find out more

Hasan HODAJ, MD

hhodaj@chu-grenoble.fr 04-76-76-52-13 Official trial record

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