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Official title Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)
ClinicalTrials.gov ID: NCT06920524
What this study is testing
- What it's testing
- Botulinum toxin (BT) injections are a painful treatment frequently used to treat spasticity following central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). Tolerance of injections varies from patient to patient.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for...
- Patients with known pain and/or anxiety
- Able to give informed consent to participate in research
- Enrolled in a French Social Security system
You likely can't join if
- Contraindication to musical intervention (severe hearing impairment, unstabilized psychotic disorders, history of auditory trauma)
- Major cognitive impairment
- Any medical condition deemed by the investigator to be incompatible with the research.
- Indication for MEOPA sedation during botulinum toxin injection sessions
- Medication or medical conditions likely to interfere with heart rate variability during the study: beta-blockers, anti-arrhythmics, anxiolytics...
- Pregnant or breast-feeding women
See the full eligibility criteria
- Adult patients, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for botulinum toxin injection treatments.
- Patients with known pain and/or anxiety
- Able to give informed consent to participate in research
- Enrolled in a French Social Security system
- Contraindication to musical intervention (severe hearing impairment, unstabilized psychotic disorders, history of auditory trauma)
- Major cognitive impairment
- Any medical condition deemed by the investigator to be incompatible with the research.
- Indication for MEOPA sedation during botulinum toxin injection sessions
- Medication or medical conditions likely to interfere with heart rate variability during the study: beta-blockers, anti-arrhythmics, anxiolytics, benzodiazepines, anti-hypertensives and calcium antagonists.
- Pregnant or breast-feeding women
- Refusal to participate
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.