Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Selän alueen poikkeava aktiivisuus servikaalisessa dystoniassa

This study is investigating cervical dystonia, a condition where people experience unusual muscle activity in their neck and shoulder area. This can cause the head to twist, tilt, or shake. The main treatment usually involves injections of medications like Botox directly into the affected muscles to relax them. This study aims to understand more about how abnormal activity in the back muscles might be involved in cervical dystonia. Researchers will compare different types of botulinum toxin injections, such as Botox and Xeomin, to see how effectively they reduce muscle overactivity and improve the symptoms of dystonia. The study will measure changes in the severity of the condition using a special rating scale.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Pirkanmaan hyvinvointialue

Enrolment target

150

Start

27 Aug 2024

Servikaalinen dystonia jossa poikkeavaa lihasaktiivisuutta esiintyy kaulan alueen lihaksissa aiheuttaen tyypillisiä virheasentoja kuten pään kiertymistä kallistumista ja vapinaa. Servikaalista dystoniaa hoidetaan ensisijaisesti paikallisesti botuliinitoksiinipistoksilla jossa poikkeavaa lihasaktiivisuutta pyritään vähentämään lamaamalla kohdelihasten toimintaa

What is this study about?

This research is looking into a condition called cervical dystonia. This happens when the muscles in your neck and sometimes your shoulders become overactive, causing your head to get stuck in unusual positions, such as twisting to one side, tilting, or shaking. It can be quite uncomfortable and affect daily life.

Usually, doctors treat cervical dystonia by giving injections of a special medicine, like Botox, directly into the overactive muscles. This medicine helps to relax the muscles and reduce the unwanted movements. This study is trying to understand if there's also unusual muscle activity in the back area that might be connected to cervical dystonia, even if the main problems are in the neck.

The main goal of this study is to compare how well different types of these muscle-relaxing injections work. Researchers will be using well-known treatments like Botox and Xeomin. They want to see which one, or what amounts, might be most effective in reducing the muscle stiffness and abnormal head positions, ultimately aiming to improve your comfort and symptoms. They will be carefully measuring any changes in your condition using a specific tool designed for dystonia.

Key takeaways

The study explores cervical dystonia and related muscle activity.
It compares different Botox-like injections for treatment.
The goal is to improve understanding and treatment of neck twisting and shaking.
Participation involves receiving standard dystonia treatments and assessments.
All adults (18+) with cervical dystonia can be considered.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years of age or older. The study welcomes both men and women.

The main requirement is that you have cervical dystonia where your neck muscles are overactive, causing your head to twist, tilt, or shake. This means the study is focused on people who are experiencing these specific symptoms.

More detailed specific requirements would be discussed with the study team to make sure it's the right fit for you. They will check your medical history to ensure your safety and that the study is suitable.

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 18 years old or older?
Have you been diagnosed with cervical dystonia?
Do you experience head twisting, tilting, or shaking due to your neck muscles?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive injections of either Botox or Xeomin, which are standard treatments for cervical dystonia. The doses will be either 50 or 100 units. You might also receive a saline solution (saltwater) injection, which is a common way to compare treatments.

The study will involve regular assessments to check how your dystonia symptoms are changing. This will include using a specific tool called the Unified Dystonia Rating Scale (UDRS) to measure how severe your condition is over time. The total duration of your participation, including the number of visits and follow-up, would be carefully explained to you by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of improved cervical dystonia symptoms, as you will be receiving treatments that are known to help with this condition. However, there are also potential risks involved, such as side effects from the injections, which will be fully explained before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is cervical dystonia?

It's a condition where your neck muscles become overactive, causing your head to twist, tilt, or shake, which can be uncomfortable.

What kind of treatments are being tested?

The study is comparing different types and doses of muscle-relaxing injections, like Botox and Xeomin, which are standard treatments for dystonia.

Why are back muscles mentioned?

Researchers are trying to understand if unusual muscle activity in your back might also play a role in cervical dystonia.

Will I get real medicine, or a dummy treatment?

You will receive either Botox, Xeomin, or a saline solution. The study team will explain what that means for you.

How will the study measure my progress?

They will use a special rating scale to track how your symptoms change and improve over time.