StrokeMUSIBOTNCT06920524
Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT)
A study testing Intervention group IM-IM in people with Stroke and Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Multiple Sclerosis, Spinal Cord Injury
- What is being tested?
- Intervention group IM-IM
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise laclautre, +33473754963, promo_inerne_drci@chu-clermontferrand.fr
Marina BADIN
About this study
Official title: Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity
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. For most patients, the pain experienced during the injection is a major source of stress.
Numerous clinical trials have demonstrated the role of music therapy in pain management. Music therapy uses a "U" shaped technique, allowing the patient to relax in different phases. This system has demonstrated beneficial effects on pain and anxiety in various fields, such as chronic and acute pain, Alzheimer's disease, fibromyalgia and neurological pain. Given the painful nature of spasticity and anxiety treatment, we aim to use a musical intervention to help patients cope better with injections.
Read more
The primary objective of the study is to investigate the effect of exposure to a musical intervention session during botulinum toxin injections, on injection-induced stress (heart rate variability).
Secondary objectives:
To study the effect of exposure to a musical intervention session during botulinum toxin injections, during the visit to injections #1, in terms of:
- Injection-induced stress for HRV parameters other than LF/HF
- Injection-induced pain
- Injection anxiety
- Patient satisfaction
- Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the doctor at the end of the session.
To study the effect of exposure to a musical intervention session, during injections visit n°2, in order to evaluate the effect of repeated exposure to a musical intervention session, in terms of :
- Injection-induced stress for HRV parameters other than LF/HF
- Injection-induced pain
- Injection anxiety
- Patient satisfaction
- Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the physician at the end of the session.
The hypothesis of this research is that a responsive musical intervention can, in adults, reduce the stress induced by botulinum toxin injections.
Patients will be selected from the cohort of patients regularly treated for botulinum toxin injections in the Physical and Rehabilitation Medicine (PRM) department at Clermont-Ferrand University Hospital. Botulinum toxin injections will take place in the PRM department. Each patient will participate in the study for a maximum of 4 months.
This study will be carried out in patients receiving regular botulinum toxin injections to treat spasticity. The first injection will be given with (IM-IM) or without musical intervention (CT-IM), depending on the randomization group, followed by the next injection with musical intervention. Patients will be able to choose the style of music (Jazz, Classical, Electronic, R\&B, Ambient, Rock, etc.) that appeals to them in order to benefit from a minimum 20-minute session of musical intervention (duration varying according to the number of injections to be performed).
- Conditions
- Stroke, Multiple Sclerosis, Spinal Cord Injury, Head Trauma Injury
- Being tested
- Intervention group IM-IM
- Keywords
- Musical intervention, Pain Management, stress, Botulinum toxin
- Medical subject headings
- Stroke, Multiple Sclerosis, Spinal Cord Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group IM-IMDevice
The intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow.
| Study group | Role | What they receive |
|---|---|---|
| Control group CT-IM : standard condition | No intervention | The control group (CT-IM) will receive no special devices, apart from the Polar H10 heart rate monitor. This group will perform botulinum toxin injections as usual in the department, with the same assessments as the IM-IM group. |
| Intervention group : IM-IM | Experimental | The intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow. Receives: Device: Intervention group IM-IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the LF (sympathic activity)
Measured: Baseline
Stress
Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the HF parameter (parasympatic activity).
The LF/HF ratio is a good reflection of the balance between sympathetic and parasympathetic nervous system activity, which can offer clues to stress regulation, cardiovascular health and physical adaptation. Thus, a low LF/HF ratio may be associated with better recovery, better emotional regulation, and a healthier balance of the autonomic nervous system.
Measured: Baseline
Secondary outcomes (6)
Stress
Patient stress during injection visit no. 2, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the parameter LF/HF.
Measured: 3 months
Intensity of pain
The intensity of pain experienced by the patient during the botulinum toxin injection session, during visits to injections n°1 and n°2, measured by a simple numerical scale (ENS) ranging from 0 ("no pain") to 10 ("the worst pain imaginable") immediately after the end of the session.
Measured: Baseline and 3 months
Variation of anxiety
Measurement of the variation in anxiety measured using the State Trait Anxiety Inventory-form Y Etat (STAI-Y1) self-questionnaire, during injection visits n°1 and n°2, before and after botulinum toxin injections. The STAI-Y1 questionnaire consists of 20 questions, measured on a Likert scale ranging from 1-" Not at all" to 4-"Very much so".
Measured: Baseline and 3 months
Measurement of perception of session time
Measurement of perception of session time in relation to actual injection time at injection visits n°1 and n°2. Declarative data collected at the end of the session during the various visits.
Measured: Baseline and 3 months
Patient satisfaction with the procedure
Patient satisfaction with the procedure assessed using a Visual Analogue Scale (VAS) ranging from 0 - "no satisfaction" to 10 - "highest satisfaction" measured after the injections, during injection visits n°1 and n°2.
Measured: Baseline and 3 months
Quality of the conditions under which botulinum toxin injections
The quality of the conditions under which botulinum toxin injections were performed, as assessed by the doctor immediately after the end of the session for injections n°1 and n°2 [using a simple numerical scale (ENS) ranging from 0 ("extremely poor conditions") to 10 ("extremely good conditions")].
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start25 Apr 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the first visit, consent will be obtained from the patient or guardian, followed by data collection (age, sex, pathology, date of first injection). Randomization will take place after this stage. All injections will follow the same protocol (tracking technique, MYOBOT 26G needle, ice analgesia on request). A Polar H10 heart rate monitor will measure the stress induced by the medical procedure. Before the injection, the patient will complete the STAI-Y1 anxiety questionnaire.The control group (CT-IM) will receive only the heart rate monitor, and will receive injections as usual. The intervention group (IM-IM) will be provided with a tablet and headphones to listen to selected music before the injection. At the end, all patients will rate their pain (VAS 0-10), anxiety (STAI-Y1) and satisfaction. Their perception of time will be compared with the actual duration of the medical procedure.At the second visit (M3±1 month), all patients will have access to music before the injection.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina BADIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920524
- Sponsor's protocol ID
- RBHP 2024 BADIN
- Other IDs
- 2024-A02840-47
- Acronym
- MUSIBOT
- Status last verified
- May 2025
- First submitted
- 27 Mar 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.
PubMed 19628939Guétin S, Giniès P, Picot MC, et al. Évaluation et standardisation d'une nouvelle technique de musicothérapie dans la prise en charge de la douleur : le montage en " U ". Douleurs Eval - Diagn - Trait. 2010;11(5):213-218. doi:10.1016/j.douler.2010.06.001
Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.
PubMed 27548494Bertacco M, Soyeux O, Durand R, Boudrias P, Wiseman L, Rompre P, Rainville P, Emami E, Gosselin N. Effect of personalized musical intervention on burden of care in dental implant surgery: A pilot randomized controlled trial. J Dent. 2022 May;120:104091. doi: 10.1016/j.jdent.2022.104091. Epub 2022 Mar 11.
PubMed 35283258Sorkpor SK, Montero-Hernandez S, Miao H, Pollonini L, Ahn H. Assessing the impact of preferred web app-based music-listening on pain processing at the central nervous level in older black adults with low back pain: An fNIRS study. Geriatr Nurs. 2023 Nov-Dec;54:135-143. doi: 10.1016/j.gerinurse.2023.09.005. Epub 2023 Oct 1.
PubMed 37782976Sorkpor SK, Miao H, Moore C, Johnson CM, Maria DMS, Pollonini L, Ahn H. Listening to Remotely Monitored Home-based Preferred Music for Pain in Older Black Adults with Low Back Pain: A Pilot Study of Feasibility and Acceptability. Pain Manag Nurs. 2023 Oct;24(5):e102-e108. doi: 10.1016/j.pmn.2023.07.001. Epub 2023 Jul 21.
PubMed 37482453Angelvy P, Badin M, Pelletier-Visa M, Givron P, Pereira B, Coudeyre E. Musical intervention to reduce stress during botulinum toxin injection for spasticity: Protocol for a randomized controlled trial (MUSIBOT). PLoS One. 2025 Nov 25;20(11):e0327259. doi: 10.1371/journal.pone.0327259. eCollection 2025.
PubMed 41289288
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity
- ClinicalTrials.gov ID
- NCT06920524
- Acronym / sponsor ID
- MUSIBOT / RBHP 2024 BADIN
- Conditions
- Stroke, Multiple Sclerosis, Spinal Cord Injury, Head Trauma Injury
- Keywords
- Musical intervention, Pain Management, stress, Botulinum toxin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. For most patients, the pain experienced during the injection is a major source of stress.
Numerous clinical trials have demonstrated the role of music therapy in pain management. Music therapy uses a "U" shaped technique, allowing the patient to relax in different phases. This system has demonstrated beneficial effects on pain and anxiety in various fields, such as chronic and acute pain, Alzheimer's disease, fibromyalgia and neurological pain. Given the painful nature of spasticity and anxiety treatment, we aim to use a musical intervention to help patients cope better with injections.
The primary objective of the study is to investigate the effect of exposure to a musical intervention session during botulinum toxin injections, on injection-induced stress (heart rate variability).
Secondary objectives:
To study the effect of exposure to a musical intervention session during botulinum toxin injections, during the visit to injections #1, in terms of:
- Injection-induced stress for HRV parameters other than LF/HF
- Injection-induced pain
- Injection anxiety
- Patient satisfaction
- Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the doctor at the end of the session.
To study the effect of exposure to a musical intervention session, during injections visit n°2, in order to evaluate the effect of repeated exposure to a musical intervention session, in terms of :
- Injection-induced stress for HRV parameters other than LF/HF
- Injection-induced pain
- Injection anxiety
- Patient satisfaction
- Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the physician at the end of the session.
The hypothesis of this research is that a responsive musical intervention can, in adults, reduce the stress induced by botulinum toxin injections.
Patients will be selected from the cohort of patients regularly treated for botulinum toxin injections in the Physical and Rehabilitation Medicine (PRM) department at Clermont-Ferrand University Hospital. Botulinum toxin injections will take place in the PRM department. Each patient will participate in the study for a maximum of 4 months.
This study will be carried out in patients receiving regular botulinum toxin injections to treat spasticity. The first injection will be given with (IM-IM) or without musical intervention (CT-IM), depending on the randomization group, followed by the next injection with musical intervention. Patients will be able to choose the style of music (Jazz, Classical, Electronic, R\&B, Ambient, Rock, etc.) that appeals to them in order to benefit from a minimum 20-minute session of musical intervention (duration varying according to the number of injections to be performed).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At the first visit, consent will be obtained from the patient or guardian, followed by data collection (age, sex, pathology, date of first injection). Randomization will take place after this stage. All injections will follow the same protocol (tracking technique, MYOBOT 26G needle, ice analgesia on request). A Polar H10 heart rate monitor will measure the stress induced by the medical procedure. Before the injection, the patient will complete the STAI-Y1 anxiety questionnaire.The control group (CT-IM) will receive only the heart rate monitor, and will receive injections as usual. The intervention group (IM-IM) will be provided with a tablet and headphones to listen to selected music before the injection. At the end, all patients will rate their pain (VAS 0-10), anxiety (STAI-Y1) and satisfaction. Their perception of time will be compared with the actual duration of the medical procedure.At the second visit (M3±1 month), all patients will have access to music before the injection.
| Arm | Type | Receives |
|---|---|---|
| Control group CT-IM : standard condition | No intervention | –The control group (CT-IM) will receive no special devices, apart from the Polar H10 heart rate monitor. This group will perform botulinum toxin injections as usual in the department, with the same assessments as the IM-IM group. |
| Intervention group : IM-IM | Experimental | Device: Intervention group IM-IMThe intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group IM-IMThe intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow. | Device | Intervention group : IM-IM |
Primary outcome
Stress
Time frame: Baseline
Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the LF (sympathic activity)
Stress
Time frame: Baseline
Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the HF parameter (parasympatic activity). The LF/HF ratio is a good reflection of the balance between sympathetic and parasympathetic nervous system activity, which can offer clues to stress regulation, cardiovascular health and physical adaptation. Thus, a low LF/HF ratio may be associated with better recovery, better emotional regulation, and a healthier balance of the autonomic nervous system.
6 secondary outcomes
Stress
Time frame: 3 months
Intensity of pain
Time frame: Baseline and 3 months
Variation of anxiety
Time frame: Baseline and 3 months
Measurement of perception of session time
Time frame: Baseline and 3 months
Patient satisfaction with the procedure
Time frame: Baseline and 3 months
Quality of the conditions under which botulinum toxin injections
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 19628939Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.
- BackgroundGuétin S, Giniès P, Picot MC, et al. Évaluation et standardisation d'une nouvelle technique de musicothérapie dans la prise en charge de la douleur : le montage en " U ". Douleurs Eval - Diagn - Trait. 2010;11(5):213-218. doi:10.1016/j.douler.2010.06.001
- Background: PubMed 27548494Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.
- Background: PubMed 35283258Bertacco M, Soyeux O, Durand R, Boudrias P, Wiseman L, Rompre P, Rainville P, Emami E, Gosselin N. Effect of personalized musical intervention on burden of care in dental implant surgery: A pilot randomized controlled trial. J Dent. 2022 May;120:104091. doi: 10.1016/j.jdent.2022.104091. Epub 2022 Mar 11.
- Background: PubMed 37782976Sorkpor SK, Montero-Hernandez S, Miao H, Pollonini L, Ahn H. Assessing the impact of preferred web app-based music-listening on pain processing at the central nervous level in older black adults with low back pain: An fNIRS study. Geriatr Nurs. 2023 Nov-Dec;54:135-143. doi: 10.1016/j.gerinurse.2023.09.005. Epub 2023 Oct 1.
- Background: PubMed 37482453Sorkpor SK, Miao H, Moore C, Johnson CM, Maria DMS, Pollonini L, Ahn H. Listening to Remotely Monitored Home-based Preferred Music for Pain in Older Black Adults with Low Back Pain: A Pilot Study of Feasibility and Acceptability. Pain Manag Nurs. 2023 Oct;24(5):e102-e108. doi: 10.1016/j.pmn.2023.07.001. Epub 2023 Jul 21.
- Derived from this study: PubMed 41289288Angelvy P, Badin M, Pelletier-Visa M, Givron P, Pereira B, Coudeyre E. Musical intervention to reduce stress during botulinum toxin injection for spasticity: Protocol for a randomized controlled trial (MUSIBOT). PLoS One. 2025 Nov 25;20(11):e0327259. doi: 10.1371/journal.pone.0327259. eCollection 2025.
- Recommandations pour les médicaments.Link provided by the sponsor.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina BADIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group IM-IM in people with Stroke and Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920524, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.