RecruitingNAINTERVENTIONAL

Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024

This study aims to discover how Deep Brain Stimulation (DBS) can be made more effective for patients with various brain conditions. DBS is a treatment where small devices are placed in the brain to send electrical signals, helping to improve symptoms. While it’s already a good option for some, doctors want to find ways to make it work even better for each individual. Researchers will carefully record brain activity during the surgery when the DBS devices are put in. By studying these recordings alongside how patients respond to the treatment, they hope to find specific 'markers' or signs in the brain activity that can predict how well DBS will help. This knowledge could lead to more personalised and successful DBS treatments in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier St Anne

Enrolment target

250

Start

18 Sep 2024

Estimated completion

25 Apr 2036

Pathology Requiring Deep Brain Stimulation Therapy

What is this study about?

Deep Brain Stimulation (DBS) is a treatment used for people with certain brain conditions, like Parkinson's disease or severe OCD, when other treatments haven't worked well. It involves placing thin wires, called electrodes, into specific areas of the brain. These wires are connected under the skin to a small device, similar to a pacemaker, usually placed in the chest or tummy. This device sends gentle electrical pulses to the brain, which can help to control symptoms. It's special because it doesn't permanently change the brain, can be adjusted, and can even be removed if needed.

While DBS is effective for many, doctors are always looking for ways to improve it and make it work even better for each person. Currently, it can sometimes take time to find the best settings for the electrical pulses. This study wants to speed up that process. During parts of the DBS surgery, there are unique opportunities to gather information directly from the brain, like recordings of its electrical activity.

This research aims to use these recordings, along with other brain scans and tests, to find specific 'biomarkers'. These are like natural signs within the brain that could tell doctors in advance how well DBS is likely to work, and what settings might be best for an individual. By identifying these markers, the hope is to make DBS therapy more personalised, more successful, and quicker to get right for people needing this life-changing treatment.

Key takeaways

The study explores how to improve Deep Brain Stimulation (DBS).
It aims to find brain 'markers' that predict DBS effectiveness.
Data will be collected during your existing DBS surgery.
This could lead to more personalised and successful treatments.
Participation is mainly integrated into your standard surgical care.

Who may be eligible?

To be considered for this study, you must be an adult who has a brain condition that your doctor believes can be treated with Deep Brain Stimulation (DBS). This could include conditions like Parkinson's disease, essential tremor, dystonia, epilepsy, or certain mental health conditions like severe Obsessive Compulsive Disorder or depression.

You should be able to understand the study and complete simple questionnaires in French. It's also important that you agree to take part and sign a consent form, showing you understand what's involved. You'll also need to have access to the UK's social security system.

However, you won't be able to join if you have any medical reasons that would make DBS surgery or general anaesthesia unsafe for you. This includes having a high risk of bleeding or infection. You also can't take part if you aren't able to complete some mental and movement-based tests that are part of the study.

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 an adult (18 years or older)?
Are you having Deep Brain Stimulation (DBS) for a brain condition?
Can you understand the study information and complete questionnaires in French?
Do you have access to the UK's social security system?
Do you not have any health reasons that would make surgery unsafe for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will happen during your planned Deep Brain Stimulation (DBS) surgery. The researchers will be collecting information from your brain while the surgeons are performing the procedure. This involves making special electrical recordings directly from your brain during the surgery itself. You will also be asked to complete some thinking and movement tests, likely before or after your surgery.

There won't be extra visits or changes to your medication beyond what your doctor would normally recommend for your DBS treatment. The total duration of your participation will mainly be centred around your surgery and immediate follow-up, as the researchers gather data to see how the recordings connect to your recovery and symptoms.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand how to make Deep Brain Stimulation (DBS) more effective and personalised for future patients, and potentially for yourself. The research aims to improve outcomes for people with conditions requiring DBS. As with any surgery, there are risks associated with the DBS procedure itself, such as potential for bleeding or infection, but these are part of the standard risks explained by your surgical team. The additional research recordings during surgery are not expected to add significant new risks. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Grenoble-Alpes Hospital Center
Verified postcode
Grenoble, France· Not yet recruiting
Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris
Verified postcode
Paris, France· Recruiting

Common questions

What is Deep Brain Stimulation (DBS)?

DBS is a treatment for certain brain conditions where a small device is put inside the body to send electrical pulses to specific brain areas, helping to control symptoms.

What is the study trying to find out?

Researchers want to find specific 'markers' in brain activity during DBS surgery that can predict how well the treatment will work for someone.

Will taking part change my actual DBS surgery?

The study involves taking extra recordings during your planned DBS surgery, but it won't change how your main surgery is performed by your medical team.

Will I need extra appointments for this study?

The main parts of the study happen during your surgery. You might also have some tests before or after, but it shouldn't add many extra appointments.

Could this research help me directly?

While the main goal is to help future patients, the insights gained could lead to better-tailored DBS for people like you.

How to find out more

Philippe Domenech, Professor, MD, PhD

philippe.domenech@ghu-paris.fr 0033(0)149812201 Official trial record

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