StrokeNCT06767631
Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
A study testing threedimensional freehand ultrasound and instrumented spasticity assessment in people with Stroke and Spasticity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Spasticity, Equinovarus Foot
- What is being tested?
- threedimensional freehand ultrasound and instrumented spasticity assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2025to 31 Dec 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- 4. Pes equinovarus due to spasticity
- 5. Clinical need for BoNT injection at the lower leg
- 6. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
- 7. First-ever, unilateral stroke
Who cannot join
- Musculoskeletal or other neurological problems affecting the lower limb
- Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- Cognitive problems that impede measurements
- Severe co-morbidities
- Irritated skin or open wounds where ultrasound will be placed
- Pregnancy
Show all 9Show fewer
- Profound atrophy of the muscles in the target area(s) of injection
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Uz Leuven
Leuven, 3000
Fabienne Schillebeeckx, MD, PhD, 0495100300, fabienne.schillebeeckx@uzleuven.be
About this study
Official title: Exploratory, Longitudinal Study to Define Changes in Muscle, Tendon and Neural Properties After Botuline Neurotoxin Type A (BoNT) Treatment of Spastic Equinovarus in First-ever Stroke Patients: a Pilot Study.
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.
Read the detailed description
TRIAL RATIONALE:
To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.
TRIAL DESIGN:
Non-blinded, non-randomized open label, longitudinal pilot interventional clinical trial.
In total, 4 visits will be organised:
- V1: Baseline visit, week 0
- V2: Injection visit, week 5-7
- V3: Follow-up visit, week 10-12:
- V4: End of study visit , week 18-30
4 visits are organized according to the biological functioning of BoNT. These 4 visits also correspond to the standard clinical visits as they currently proceed when a patient is treated with BoNT. At baseline visit (week 0) and injection visit (week 6) we do not expect any changes in outcome parameters since no BoNT has been injected yet. The effect of BoNT has peak effects after 4-6 weeks and a duration of action between 2 and 6 months. At follow-up visit (week 10-12) and end-of-study visit (when BoNT is clinically elaborated, week 18-30) we expect corresponding changes in outcome parameters, respectively.
At each visit, 3DfUS measurements and ISA measurements will be performed on two muscles of both legs: 1) medial gastrocnemius muscle and 2) tibialis anterior muscle. The majority of US literature in the lower limb has focused on medial gastrocnemius. Additionally, these muscles are obvious candidates because of their functional importance in locomotion. Moreover, the medial gastrocnemius is a frequently injected muscle with BoNT, whereas tibialis anterior muscle is not. From a methodological perspective, both medial gastrocnemius and tibialis anterior are superficial and can be easily tracked by means of conventional US probes and EMG electrodes.
During visit 2, a pregnancy test will be conducted prior to the injection of Botulinum toxin. If the test is positive, the study will be discontinued, and the patient will not be treated with Botulinum toxin A.
Total duration of one visit will be 1.5 to 2 hours. All measurements of one visit take place on the same day. Measurements will be performed at the University Hospital Leuven.
For this study, stroke patients treated with BoNT for spastic equinovarus will be included. In particular stroke patients are patients that are being treated at the University Hospital, Leuven. The annual number of stroke patients seen in UZ Leuven is approximately 600 per year.
- Conditions
- Stroke, Spasticity, Equinovarus Foot
- Being tested
- threedimensional freehand ultrasound and instrumented spasticity assessment
- Keywords
- Botulinum Toxins, stroke, Medial Gastrocnemius Muscle, Skeletal muscle morphology, muscle composition
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
threedimensional freehand ultrasound and instrumented spasticity assessmentDiagnostic test
To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients treated with Botulinum toxine injections for spastic equinovarus | Other | This study involves a single-arm, exploratory, longitudinal design focusing on first-time stroke patients with spastic equinovarus deformity. Participants will receive Botulinum Neurotoxin Type A (BoNT-A) injections targeting medial and lateral gastrocnemius muscle as well ass soleus muscle. The intervention aims to assess changes in muscle, tendon, and neural properties before and after treatment by using instrumented spasticity assessment and threedimensional freehand ultrasound Receives: Diagnostic Test: threedimensional freehand ultrasound and instrumented spasticity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
sample size calculation
To estimate the number of subjects to calculate an appropriate sample size for assessing changes in muscle, tendon and neural properties after BoNT treatment of spastic equinovarus in first-ever stroke patients by using 3DfUS and ISA in a future observational study. To calculate standard deviation and effect sizes of outcome measures obtained with 3DfUS and ISA in these patients.
Measured: 2 years
Secondary outcomes (28)
muscle changes
Secondary outcome parameters measured by 3DfUS include muscle belly length for medial gastrocnemius muscle
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA for slow stretch measured by ISA : maximal velocity of performance (Vmax [deg/s])
Measured: 2 years
functional changes
Medical baseline data including age, gender, body mass index, time since stroke, stroke etiology, National Institute Health Stroke Scale [15], affected side, oral medication and adverse events will be collected at each visit from the patients medical file as they are part of standard of care:
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS include tendon length for medial gastrocnemius muscle
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS include mid-belly cross-sectional area for medial gastrocnemius muscle
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS include muscle belly length for tibial anterior muscle
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS mid-belly cross-sectional area for tibial anterior muscle
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS include mean Echo Intensity for tibial anterior muscle
Measured: 2 years
muscle changes
Secondary outcome parameters measured by 3DfUS include mean Echo Intensity for medial gastrocnemius muscle
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA for slow stretch measured by ISA : range of motion [deg]
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA for slow stretch measured by ISA: stiffness [Nm/deg]
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA for slow stretch measured by ISA work [J] (area under the power-time curve).
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA from the fast stretch: maximal velocity of performance (Vmax [deg/s])
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA from the fast stretch: joint angle of catch [deg]
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA from the fast stretch: angle of EMG threshold [deg]
Measured: 2 years
neural changes
Secondary outcome parameters measured by ISA from the fast stretch: intensity of catch (power [W]; torque times angular velocity).
Measured: 2 years
functional changes
Modified Asworth Scale
Measured: 2 years
functional changes
Tardieu scale
Measured: 2 years
functional changes
Barthel Index
Measured: 2 years
functional changes
Functional Ambulation Categories
Measured: 2 years
functional changes
the Rivermead Mobility Index
Measured: 2 years
functional changes
Functional Independence Measure
Measured: 2 years
functional changes
Fugl-Meyer scale
Measured: 2 years
functional changes
Modified Rankin Scale
Measured: 2 years
functional changes
5 Meter Timed Walking Test
Measured: 2 years
functional changes
Motricity Index
Measured: 2 years
functional changes
Five-Times Sit-to-Stand Test
Measured: 2 years
functional changes
Gait analyses
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Schillebeeckx, MD, Principal investigator, UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767631
- Sponsor's protocol ID
- S68672
- Other IDs
- Trial number 2024-513158-32-00
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanssen B, De Beukelaer N, Schless SH, Cenni F, Bar-On L, Peeters N, Molenaers G, Van Campenhout A, Van den Broeck C, Desloovere K. Reliability of Processing 3-D Freehand Ultrasound Data to Define Muscle Volume and Echo-intensity in Pediatric Lower Limb Muscles with Typical Development or with Spasticity. Ultrasound Med Biol. 2021 Sep;47(9):2702-2712. doi: 10.1016/j.ultrasmedbio.2021.04.028. Epub 2021 Jun 8.
PubMed 34112554
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Longitudinal Study to Define Changes in Muscle, Tendon and Neural Properties After Botuline Neurotoxin Type A (BoNT) Treatment of Spastic Equinovarus in First-ever Stroke Patients: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06767631
- Acronym / sponsor ID
- S68672
- Conditions
- Stroke, Spasticity, Equinovarus Foot
- Keywords
- Botulinum Toxins, stroke, Medial Gastrocnemius Muscle, Skeletal muscle morphology, muscle composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 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.
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.
Detailed description
TRIAL RATIONALE:
To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.
TRIAL DESIGN:
Non-blinded, non-randomized open label, longitudinal pilot interventional clinical trial.
In total, 4 visits will be organised:
- V1: Baseline visit, week 0
- V2: Injection visit, week 5-7
- V3: Follow-up visit, week 10-12:
- V4: End of study visit , week 18-30
4 visits are organized according to the biological functioning of BoNT. These 4 visits also correspond to the standard clinical visits as they currently proceed when a patient is treated with BoNT. At baseline visit (week 0) and injection visit (week 6) we do not expect any changes in outcome parameters since no BoNT has been injected yet. The effect of BoNT has peak effects after 4-6 weeks and a duration of action between 2 and 6 months. At follow-up visit (week 10-12) and end-of-study visit (when BoNT is clinically elaborated, week 18-30) we expect corresponding changes in outcome parameters, respectively.
At each visit, 3DfUS measurements and ISA measurements will be performed on two muscles of both legs: 1) medial gastrocnemius muscle and 2) tibialis anterior muscle. The majority of US literature in the lower limb has focused on medial gastrocnemius. Additionally, these muscles are obvious candidates because of their functional importance in locomotion. Moreover, the medial gastrocnemius is a frequently injected muscle with BoNT, whereas tibialis anterior muscle is not. From a methodological perspective, both medial gastrocnemius and tibialis anterior are superficial and can be easily tracked by means of conventional US probes and EMG electrodes.
During visit 2, a pregnancy test will be conducted prior to the injection of Botulinum toxin. If the test is positive, the study will be discontinued, and the patient will not be treated with Botulinum toxin A.
Total duration of one visit will be 1.5 to 2 hours. All measurements of one visit take place on the same day. Measurements will be performed at the University Hospital Leuven.
For this study, stroke patients treated with BoNT for spastic equinovarus will be included. In particular stroke patients are patients that are being treated at the University Hospital, Leuven. The annual number of stroke patients seen in UZ Leuven is approximately 600 per year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients treated with Botulinum toxine injections for spastic equinovarus | Other | Diagnostic Test: threedimensional freehand ultrasound and instrumented spasticity assessmentThis study involves a single-arm, exploratory, longitudinal design focusing on first-time stroke patients with spastic equinovarus deformity. Participants will receive Botulinum Neurotoxin Type A (BoNT-A) injections targeting medial and lateral gastrocnemius muscle as well ass soleus muscle. The intervention aims to assess changes in muscle, tendon, and neural properties before and after treatment by using instrumented spasticity assessment and threedimensional freehand ultrasound |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- 4. Pes equinovarus due to spasticity
- 5. Clinical need for BoNT injection at the lower leg
Key exclusion criteria (9 listed)
- Musculoskeletal or other neurological problems affecting the lower limb
- Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- Cognitive problems that impede measurements
- Severe co-morbidities
- Irritated skin or open wounds where ultrasound will be placed
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 |
|---|---|---|
| threedimensional freehand ultrasound and instrumented spasticity assessmentTo conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population. | Diagnostic test | stroke patients treated with Botulinum toxine injections for spastic equinovarus |
Primary outcome
sample size calculation
Time frame: 2 years
To estimate the number of subjects to calculate an appropriate sample size for assessing changes in muscle, tendon and neural properties after BoNT treatment of spastic equinovarus in first-ever stroke patients by using 3DfUS and ISA in a future observational study. To calculate standard deviation and effect sizes of outcome measures obtained with 3DfUS and ISA in these patients.
28 secondary outcomes
muscle changes
Time frame: 2 years
neural changes
Time frame: 2 years
functional changes
Time frame: 2 years
muscle changes
Time frame: 2 years
muscle changes
Time frame: 2 years
muscle changes
Time frame: 2 years
muscle changes
Time frame: 2 years
muscle changes
Time frame: 2 years
muscle changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
neural changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
functional changes
Time frame: 2 years
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 29 Apr 2026.
- Background: PubMed 34112554Hanssen B, De Beukelaer N, Schless SH, Cenni F, Bar-On L, Peeters N, Molenaers G, Van Campenhout A, Van den Broeck C, Desloovere K. Reliability of Processing 3-D Freehand Ultrasound Data to Define Muscle Volume and Echo-intensity in Pediatric Lower Limb Muscles with Typical Development or with Spasticity. Ultrasound Med Biol. 2021 Sep;47(9):2702-2712. doi: 10.1016/j.ultrasmedbio.2021.04.028. Epub 2021 Jun 8.
- Individual participant dataSharing planned: No
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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.
Fabienne Schillebeeckx, MD principal investigator
UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing threedimensional freehand ultrasound and instrumented spasticity assessment in people with Stroke and Spasticity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 9 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 29 Apr 2026. 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 Belgium. 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 Fabienne Schillebeeckx, MD, PI (0032 - 16338714, fabienne.schillebeeckx@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sample size calculation (time frame: 2 years). 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 NCT06767631, which also lists 1 linked publication.
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 29 Apr 2026.