Not yet recruitingNAINTERVENTIONAL

Alpha tACS for Disorders of Consciousness : a Single Case Experimental Design

This study is investigating a new brain stimulation method called alpha tACS for people who have experienced a severe traumatic brain injury and are in a disorder of consciousness, like a minimally conscious state. Currently, treatment options are very limited. Researchers want to see if repeatedly applying this gentle electrical stimulation to the brain can improve a person's level of awareness and change how their brain functions. This is a small, careful study where five adults will receive both the stimulation and non-stimulation periods over three months. The aim is to understand if this treatment shows promise for future, larger studies and to help develop new ways to support recovery for people with these challenging conditions.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

01 Jan 2026

Estimated completion

01 Jun 2028

Disorder of Consciousness

What is this study about?

This study is looking into a new way to help people who have a 'disorder of consciousness' after a serious head injury. This means they are in a state where they might be awake but not fully responsive, often called a minimally conscious state or a vegetative state. At the moment, there aren't many treatments that can help people recover from these conditions.

The research focuses on a gentle type of brain stimulation called 'alpha tACS'. This treatment uses very mild electrical currents, delivered through electrodes on the scalp, which are designed to influence specific brainwaves, particularly those related to alertness and how different parts of the brain work together. The idea is that improving these brainwaves might help improve a person's awareness and how their brain communicates.

This study will involve a small group of five adults who have had a head injury between 3 and 12 months ago. Each person will go through several two-week periods over three months, sometimes receiving the brain stimulation and sometimes not. This special study design allows researchers to see how each individual responds to the treatment. They will carefully check for any changes in a person's awareness using special scales, and they will also look at brain activity using scans and other tests to see if the stimulation is having the desired effect. If this small study shows promising results, it could lead to bigger studies and new treatment options in the future.

Key takeaways

Exploring a new gentle brain stimulation for disorders of consciousness.
A small, careful study over three months for people with head injuries.
Each patient acts as their own control, comparing stimulation vs. non-stimulation.
Checks include awareness scales, brainwave tests (EEG), and brain scans (MRI).
Aims to understand if this treatment shows promise for future larger studies.
Most side effects are minor and temporary; you can leave the study at any time.

Who may be eligible?

To take part in this study, you would need to be an adult between 18 and 70 years old. You would also need to have a disorder of consciousness that started between 3 and 12 months ago due to a head injury. This condition should be a vegetative state (sometimes called unresponsive wakefulness syndrome) or a minimally conscious state, and you should not have shown signs of moving out of a minimally conscious state.

There are also some reasons why someone might not be able to join the study. For example, if you have active epilepsy, major brain conditions that were present before your injury, or if you've had certain types of brain surgery that left metal implants (other than titanium) or without bone replacement. You also couldn't take part if you have certain metal devices in your body that would make an MRI scan unsafe, if you're pregnant or breastfeeding, or if you are in a situation where your freedom is restricted.

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 70 years old?
Did your current disorder of consciousness start 3 to 12 months ago due to a head injury?
Do you have a vegetative state or minimally conscious state?
Do you have epilepsy or have major brain conditions from before your injury?
Do you have certain metal implants in your body that could affect an MRI scan?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for three months. During this time, you will have six different two-week periods. Three of these periods will involve receiving the gentle brain stimulation called alpha tACS, and three will be 'non-stimulation' periods where you don't receive the tACS. Throughout the study, your level of consciousness will be checked three times each week using a special assessment scale. You will also have tests like EEG (which records brain waves) and MRI scans to look at your brain activity and structure. These are non-invasive tests and do not involve surgery. You will not be given any new medication as part of this trial.

Potential risks and benefits

This study is exploring a new treatment, so there's no guarantee it will directly benefit you. However, by taking part, you would be helping researchers learn more about disorders of consciousness, which could help future patients. The gentle brain stimulation (tACS) is generally considered safe, with most people only feeling minor, temporary things like a tingling sensation, slight skin redness, or seeing brief flashes of light during the treatment. EEG and MRI scans are also very safe procedures. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Post-Intensive Care Neurorehabilitation Unit (Service de Reeducation Post-Reanimation) in Pierre Wertheimer Neurologic Hospital
Verified postcode
Bron, France

Common questions

What is 'alpha tACS'?

Alpha tACS is a gentle brain stimulation that uses tiny electrical currents through pads on your scalp to try and change specific brainwaves, which might help improve awareness.

Will I know if I'm getting the real stimulation or not?

No, the study is designed so that neither you nor the care team will know during the non-stimulation periods. This helps ensure fair and accurate results.

How long will the study last?

The study will last for a total of three months, divided into two-week periods of stimulation or non-stimulation.

Are there any strong side effects from this stimulation?

Most people only feel minor, temporary effects like tingling, slight skin redness, or seeing brief light flashes. It is generally considered very safe.

What do the researchers hope to achieve with this study?

They hope to see if this new stimulation can improve awareness and brain activity in people with disorders of consciousness, helping to gather evidence for future larger studies.

How to find out more

Caroline HERAULT, DR

caroline.herault01@chu-lyon.fr 04 72 35 78 95 Official trial record

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