RecruitingNAINTERVENTIONAL

Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis

This study is about a device called a Grasp Neuroprosthesis (GNP) designed to help people who've had a stroke regain the ability to open and close their hand. Many stroke survivors find it hard to use their hand for everyday tasks, which can affect their independence and quality of life. The GNP uses gentle electrical pulses to stimulate muscles, making it easier to grasp things. It's been tested in hospitals, and previous home trials showed it was helpful. Now, researchers want to extend its home use to two patients for a year, to understand its long-term benefits and how it can improve daily life.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

20 Apr 2026

Estimated completion

30 Apr 2027

Stroke Réhabilitation

What is this study about?

When someone has a stroke, it can sometimes make it very difficult to move parts of their body, including their hands. For many, even after rehabilitation, opening their hand to pick things up or let go can remain a big challenge. This can make simple daily activities, like eating or dressing, much harder than before.

This is where a special device called a Grasp Neuroprosthesis, or GNP, comes in. Think of it as a clever helper for your hand. It's a wearable device, a bit like a soft sleeve for your forearm, that uses small, safe electrical pulses. These pulses gently tell your hand muscles to open when you want them to, helping you to grasp and release objects more easily. It's designed to give people who've had a stroke more control over their hand movements.

Researchers have been developing and testing this GNP for a few years now. They've found that it can really make a difference, helping people use their hand more effectively. They've also seen that it can be safely used at home. This new part of the study aims to see how much of a difference the GNP can make over a longer period, specifically one year, when used as part of daily life at home. They will monitor how it helps with everyday tasks and overall well-being.

Key takeaways

This study evaluates a device helping stroke survivors open their hands.
It aims to understand long-term home use of the Grasp Neuroprosthesis (GNP).
The GNP uses gentle electrical stimulation for hand movement.
Participation involves home visits and remote support over one year.
The goal is to improve daily independence and quality of life.

Who may be eligible?

To be considered for this study, you would need to have previously taken part in and successfully completed a study called GRASP-AGAIN, and that study must have shown that the GNP device helped you to move your arm better.

You also need to have had a single stroke (either an ischemic stroke or a hemorrhagic stroke) that caused weakness in one of your arms. This stroke must have happened at least a month ago. A key part of being eligible is that you struggle with opening your fingers or thumb to pick up certain objects, even though you can hold them if placed in your hand. You must also be able to sit comfortably and focus for about 1.5 hours and be part of a social security scheme, which most people in the UK are.

However, some things would mean you couldn't join. For example, if you are pregnant or breastfeeding. Also, if your fingers or wrist are very stiff and can't be opened passively, or if you can't move your arm close enough to your body to use the hand, you wouldn't be able to participate.

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.

Did I take part in and finish the GRASP-AGAIN study, and did that study show I improved using the GNP?
Did I have a single stroke at least one month ago that affected one of my arms?
Do I struggle to actively open my fingers or thumb to pick things up, even if I can hold them if they're placed in my hand?
Can I sit and concentrate for about 1.5 hours?
Am I NOT pregnant or breastfeeding?
Are my fingers and wrist flexible enough to be gently opened?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of two patients using the Grasp Neuroprosthesis (GNP) at home for a whole year. You'll have two main visits to the hospital: one at the very beginning to get set up and assessed, and another at the end of the year to see how you've progressed. Throughout the year, there will be monthly check-ups at your home to see how you're getting on with the device and if you need any adjustments. You'll also have the option for video calls with the study team whenever you need extra support or have questions. The staff will provide the GNP device and show you exactly how to use it safely and effectively. There's no specific medication involved in this study.

Potential risks and benefits

Participating in this study might offer significant benefits, such as improved independence in daily tasks by helping you open your hand more easily, potentially enhancing your quality of life. The device has been tested before and found to be safe. As with any new device, there might be minor risks like skin irritation from the electrodes, but these would be carefully monitored by the study team. You have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (1)

David GASQ
Verified postcode
Toulouse, France· Recruiting

Common questions

What exactly is a Grasp Neuroprosthesis (GNP)?

It's a wearable device, like a soft forearm sleeve, that uses gentle electrical pulses to help people who've had a stroke open their hand and fingers more easily to grasp objects.

How does the GNP help people after a stroke?

Many people after a stroke struggle to open their hand. The GNP activates the muscles that open your fingers and thumb, making it easier to pick up, hold, and release things.

Will I need to go to the hospital a lot if I join?

No, you'll have two hospital visits (at the beginning and end of the year). Most of the follow-up will be monthly visits at your home and video calls.

Is the device safe to use at home?

Yes, previous studies have shown it's safe for home use, and it has a CE medical marking, which means it meets European safety standards for medical devices.

What if I decide I don't want to continue with the study?

You are free to leave the study at any time without giving a reason, and it won't affect your regular medical care.

How to find out more

David GASQ, MD

gasq.d@chu-toulouse.fr 5 61 34 00 56 Official trial record

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