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Study on the Effects of Botulinum Toxin A for Improving Arm Function in Patients with Chronic Stroke

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for individuals who have experienced a stroke. The treatment being tested is an injection of botulinum toxin type A, known by the brand name Dysport. This medication is administered as a solution for injection and is specifically used to address muscle issues that can occur after a stroke, such as muscle stiffness or spasms in the arm.

The purpose of the study is to evaluate how these injections can help reduce unwanted muscle contractions in the arm, particularly when trying to extend the elbow. Participants in the study will receive injections of the medication into the muscles that flex the elbow. The study will observe changes in muscle activity and movement ability over time, comparing results before and after the treatment.

Throughout the study, participants will undergo various assessments to measure muscle function and movement. These assessments will help determine the effectiveness of the treatment in improving arm function after a stroke. The study aims to provide valuable insights into how botulinum toxin type A can be used to enhance recovery and improve quality of life for individuals affected by stroke-related muscle issues.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having experienced a stroke more than 6 months ago and being over 18 years old.

Informed consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted to evaluate the ability to extend the elbow actively by at least 20 degrees.

The assessment also checks for limitations in elbow movement or reduced speed of movement.

3 treatment administration

The treatment involves an intramuscular injection of botulinum toxin type A into the elbow flexor muscles.

The product used is Dysport 500 U, which is a solution for injection.

4 post-treatment evaluation

Four weeks after the injection, a follow-up evaluation is conducted.

The primary focus is on measuring the spastic cocontraction index during active elbow extension.

5 secondary assessments

Additional assessments include evaluating spasticity, movement limitations, and motor function using various tests such as the Fugl-Meyer score and the Wolf Motor Function Test.

Brain activity and motor pathway conditions are also assessed using EEG and MRI techniques.

Who Can Join the Study?

  • For the patient group, you must have had a stroke (either ischemic or hemorrhagic) more than 6 months ago. A stroke is a medical condition where blood flow to a part of the brain is interrupted or reduced.
  • For the control group, you must be older than 18 years.
  • You need to sign an informed consent form, which means you agree to participate in the study after understanding all the details.
  • For the patient group, you should have a reason to receive a TBA injection in the elbow flexor muscles. TBA stands for botulinum toxin type A, a treatment used to reduce muscle activity.
  • You must be prescribed the specific medication abobotulinumtoxinA (known as DYSPORT®).
  • You should be able to actively extend your elbow by at least 20 degrees.
  • Your active elbow extension movement should be limited by at least 15 degrees, or you should perform the movement at a speed reduced by 50%.
  • You should be either new to TBA treatment or have had your first TBA injection more than 4 months ago, specifically targeting the elbow flexors.
  • For the patient group, you must be older than 18 years.
  • You need to sign an informed consent form, agreeing to participate in the study.
  • You must be affiliated with a social security scheme, meaning you have some form of health insurance or coverage.

Who Cannot Join the Study?

  • Patients who have had a recent stroke (a medical condition where blood flow to a part of the brain is stopped or reduced).
  • Patients who are not able to understand or follow the study instructions.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a mental health condition that might affect their ability to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Clqtxf Hoivzoiltsy Dz Sm Awljq Lpc Ebcw St Amand Les Eaux France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
18.12.2020

Trial locations

Investigated drugs:

Botulinum Toxin A is used in this trial to help reduce muscle stiffness and spasms in the elbow flexors. It is injected into the muscles to help improve movement in patients who have chronic hemiplegia due to a stroke. The goal is to see if these injections can decrease unwanted muscle contractions during active elbow extension.

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells beginning to die within minutes. There are two main types of stroke: ischemic, caused by a blockage in an artery, and hemorrhagic, caused by a blood vessel leaking or bursting. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and difficulty walking. The effects of a stroke depend on the part of the brain affected and the extent of the damage. Recovery and progression can vary widely among individuals, with some experiencing significant improvement and others having long-term disabilities.

Trial ID:
2024-518147-37-00
Protocol code:
RC31/17/0455
Trial Phase:
Therapeutic exploratory (Phase II)

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