Not recruiting

Study on the Effectiveness of Botulinum Toxin Type A for Patients with Cervical Dystonia and Abnormal Muscle Activity

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as cervical dystonia. This is a disorder where there is abnormal muscle activity in the neck area, leading to unusual head positions such as twisting, tilting, and tremors. The primary treatment for cervical dystonia involves injections of botulinum toxin type A, which helps reduce the abnormal muscle activity by temporarily weakening the targeted muscles.

The purpose of this study is to explore the presence of abnormal muscle activity in the back muscles of individuals with cervical dystonia. In the second phase, the study will investigate the effectiveness and possible side effects of botulinum toxin injections in the back muscles for those who show abnormal activity in this area. The study will use different formulations of botulinum toxin, including Botox and Xeomin, which are administered through intramuscular injections. Some participants may receive a placebo as part of the study design.

Participants will undergo a series of assessments to monitor changes in the severity of their dystonia. The study will take place over a period of several months, with regular follow-up visits to evaluate the treatment's impact and any side effects. The goal is to better understand how botulinum toxin can be used to manage symptoms in patients with cervical dystonia who also have abnormal back muscle activity.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing informed consent. This involves understanding the study's purpose and agreeing to take part.
Step 2
Initial assessment
An initial assessment is conducted to evaluate muscle activity in the neck and back. This helps determine the presence of abnormal muscle activity associated with cervical dystonia.
Step 3
Treatment phase
The treatment involves intramuscular injections of botulinum toxin type A. The specific products used are Botox and Xeomin, available in 50 and 100 unit doses.
The injections aim to reduce abnormal muscle activity by temporarily weakening the targeted muscles.
Step 4
Monitoring and evaluation
The effectiveness of the treatment and any side effects are monitored. This includes assessing changes in the severity of dystonia using the Unified Dystonia Rating Scale (UDRS).
Regular follow-ups are scheduled to track progress and adjust treatment if necessary.
Step 5
End of study
The study is expected to conclude by June 30, 2026. At this point, a final evaluation is conducted to assess the overall outcomes of the treatment.

Who can join the trial?

4 criteria

Must be over 18 years old.
Must have a condition called cervical dystonia. This means there is unusual muscle activity in the neck and shoulder area, causing the head to move or be positioned in an unusual way, like tilting or turning.
Must be receiving regular treatment with botulinum toxin for cervical dystonia. Botulinum toxin is a medicine used to reduce unusual muscle activity.
Must voluntarily agree to participate in the study after being informed about it.

Who cannot join the trial?

6 criteria

Individuals who are not experiencing abnormal muscle activity in the neck area, which causes unusual head positions like twisting, tilting, or shaking.
Individuals who are not primarily treated with local injections of botulinum toxin to reduce abnormal muscle activity by weakening the target muscles.
Individuals who do not have abnormal muscle activity in the chest and lower back areas.
Individuals who are not between the ages of 18 and 65.
Individuals who are not both male and female.
Individuals who belong to a vulnerable population, which means they might need special protection or care.

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Verified
Pirkanmaan hyvinvointialue
Tampere, Finland

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Investigated drugs

Botulinum Toxin is used in this clinical trial to treat abnormal muscle activity in the back muscles of individuals with cervical dystonia. The study aims to evaluate the effectiveness and possible side effects of this treatment when injected into the back muscles.

What is already known about the treatment

Botulinum Toxin – This medication is administered through local injections directly into the muscles. It is currently used in medical practice and literature for treating cervical dystonia, a condition characterized by abnormal muscle activity in the neck, leading to unusual postures such as head twisting, tilting, and tremors. The main therapeutic indication is to reduce this abnormal muscle activity by temporarily paralyzing the targeted muscles. At the molecular level, botulinum toxin works by blocking the release of a neurotransmitter called acetylcholine, which is necessary for muscle contraction. It is classified pharmacologically as a neuromuscular blocker.

Investigated diseases

Cervical Dystonia – Cervical dystonia is a neurological disorder characterized by abnormal muscle activity in the neck muscles, leading to involuntary movements and awkward postures such as twisting, tilting, or tremors of the head. The condition progresses with varying degrees of muscle contractions, which can cause discomfort and affect daily activities. Over time, the symptoms may fluctuate, with periods of worsening and improvement. The exact cause of cervical dystonia is not well understood, but it involves a dysfunction in the brain's ability to control muscle movements. The disorder can affect individuals of any age, but it is more commonly seen in middle-aged adults.