Selective MutismNCT06882629
VR Homework Exercises for Selective Mutism Treatment
A study testing 'Speaking at school, a matter of doing' combined with VR homework exercises in people with Selective Mutism and Anxiety Disorder of Childhood, run by Luuk Stapersma at 1 site in Netherlands.
Trial summary
Selective mustism (SM) is an anxiety disorder that manifests in childhood. Children with Children with SM do not speak in certain social situations where this is expected of them. For example, a child may talk at home, but is afraid to speak at school. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Selective Mutism, Anxiety Disorder of Childhood
- What is being tested?
- 'Speaking at school, a matter of doing' combined with VR homework exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2025to Jun 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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child meets the DSM-5 criteria for SM (as a primary classification).
- The child is attending primary school.
- Referred to an academic center for Child and Adolescent Psychiatry (Levvel) for diagnosis and treatment of SM
- Psychiatric comorbidity is permitted, given that SM is the primary treatment target.
- Medication use is permitted, if stable for at least 4 weeks prior to the start of treatment.
Who cannot join
- No participating parents.
- Parents do not have sufficient mastery of the Dutch language.
- Parents or child have an estimated IQ below 75.
- The child needs inpatient treatment.
- Children with a (medical) condition that is a contraindication for using a VR headset (epilepsy, claustrophobia, facial condition, sensitive vestibular system, panic attacks)
- Parents receiving parental guidance which is not part of the standard treatment program.
- Children that have received protocolled behavior therapy for SM in the past 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Levvel
Amsterdam, North Holland, 1076 EC
Luuk Stapersma, +31 2 890 16 71, l.stapersma@levvel.nl
About this study
Official title: The Effect of Virtual Reality Homework Exercises as an Add-On to Behavioral Therapy for Children With Selective Mutism
Selective mustism (SM) is an anxiety disorder that manifests in childhood. Children with Children with SM do not speak in certain social situations where this is expected of them. For example, a child may talk at home, but is afraid to speak at school. The goal of this clinical trial is to determine the efficacy of behavioral therapy for children with selective mutism (SM) combined with virtual reality (VR) homework exercises. Virtual Reality Exposure is an effective treatment for adults with anxiety disorders.
The main questions to answer are:
Read more
- Is behavioral therapy combined with VR homework exercises effective in the treatment of SM?
- Which familial factors contribute to a positive treatment outcome and homework adherence?
A single-case experimental design (SCED) will be used to evaluate the efficacy of the treatment. The child's speaking behavior at baseline will be compared to the child's speaking behavior in the different phases of the intervention.
Participants will:
- Follow individual therapy sessions at school.
- Practice with the VR homework exercises at least once a week.
- Parents and teachers will evaluate the child's speaking behavior.
Read the detailed description
The treatment in this study consists of behavioral therapy for SM (with the protocol 'Talking at school, a matter of doing') with the addition of the VR homework exercises. The protocol consists of 10 steps that help the child to gain confidence while speaking at school. The individual therapy sessions are provided at school. For every step of the protocol there are VR homework exercises available. Families receive a VR headset for the duration of the study. Parents are instructed to work on the VR homework exercises at least once a week and encouraged to work on the VR homework exercises several times a week. On average, treatment is approximately 25 weeks.
- Conditions
- Selective Mutism, Anxiety Disorder of Childhood
- Being tested
- 'Speaking at school, a matter of doing' combined with VR homework exercises
- Keywords
- Virtual reality, Virtual reality exposure therapy, Intervention, Treatment, Children, Anxiety
- Medical subject headings
- Mutism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Speaking at school, a matter of doing' combined with VR homework exercisesBehavioural
The treatment in this study consists of behavioral therapy for selective mutism (with the protocol 'Speaking at school, a matter of doing') with the addition of the VR homework exercises. The protocol consists of 10 steps that help the child to gain confidence while speaking at school. For every treatment step there are VR homework exercises available. Families receive a VR headset for the duration of the study. Parents are instructed to work on the VR homework exercises at least once a week and encouraged to work on the VR homework exercises several times a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral: 'Speaking at school, a matter of doing' combined with VR homework exercises Receives: Behavioral: 'Speaking at school, a matter of doing' combined with VR homework exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
SM symptoms (frequent measurement)
Both parents and teachers are asked to report on SM symptoms. This is done by answering 9 yes/no questions on the child's speaking behavior and communication, including non-verbal communication, making sounds and conversing with others (more yes indicates more speaking behavior). The short assessment is specifically designed for this study in collaboration with experienced SM therapists and a statistician, specialized in SCED's.
Measured: During the baseline period (2 weeks), during the intervention phase (up to 1 year) and during follow-up (3 months after end of intervention phase), three times a week
SM symptoms (SMQ-NL)
Evaluated by parents. The SMQ consists of 23 questions that are scored on a 4-point Likert scale ranging from "always" to "never." The symptom subscale consists of 17 questions (0-68; higher scores indicate more SM symptoms), that assess the severity of the symptoms across different situations (family, school and public situations). The second subscale indicates to what extend a child experiences problems due to not speaking in certain situations.
Measured: Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase, immediately after intervention (up to 4 months), at follow-up (3 months after end of intervention)
SM symptoms (Social context of speaking)
The questionnaire consists of 16 questions assessing (0-64; higher scores indicate less SM symptoms) the social context of speaking assesses the severity of symptoms at school across different social situations (e.g. their own teacher, another teacher, in the classroom or in the presence of peers), speaking behaviour (e.g. whispering and functional speech) and its interference at school. Teachers are asked to evaluate how often child is showing different speaking behaviours and in which social context on a 4-point Likert scale. The questionnaire includes 8 questions that are based on the School Speech Questionnaire (SSQ). For the purpose of our study, the SSQ does not provide enough detail on the child's speaking behaviour, for that reason 8 more questions were included.
Measured: Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase (up to 4 months), immediately after intervention, at follow-up (3 months after end of intervention)
Secondary outcomes (16)
VR data
Each parent has a unique ID to sign-in to a web-based application that is used to guide the child through the virtual school. Parents will indicate that when the next exercise is presented. These responses are saved. Every time the parent signs in, the total time and the time spent playing the different games will be automatically stored on a secured database. This will be recorded in seconds.
Measured: During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)
VR completion
Parents are asked to track the time they spend working on the VR homework exercises on a VR tracking sheet on a weekly basis. They are asked to fill out how long and which days they practiced. The number of days practiced will be divided by the total number of days in the week. This yields a percentage of VR completion per week.
Measured: During the intervention phase (once a week, up to 1 year)
VR immersion
Specifically for this study three questions were designed to measure the level of immersion children experience while practicing with the VR. Children are asked to rate their immersive experience on 4-point Likert scale ranging from strongly disagree to strongly agree.
Measured: During the intervention phase (once a month, up to 1 year)
Structured Clinical Interview for DSM-5 Junior (SCID-5-Junior)
Semi-structured interview for children and adolescents between 8 -18. The interview is suitable for both children and their parents. The SCID-5 Junior consists of 17 modules to classify DSM-5 disorders. The SCID-5 Junior is used in standard clinical care, to check for additional anxiety disorders and disorders that might look like SM. The SCID-5 Junior will be administered in the same manner as in regular clinical care, meaning that parents only report on the modules: anxiety, autism and obsessive-compulsive behavior, unless there are indications that suggest the presence of another co-morbid disorder.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Fear Survey Schedule for Children - Revised (FSSC-R or in Dutch VAK 4-12)
The FSSC-R / VAK 4-12 is a self-report questionnaire that consists of 80 items (0-240; higher scores indicate more anxiety symptoms). The items are descriptions of objects or situations that may cause anxiety. The questionnaire can be administered verbally for children who are not able to read. Children are asked to indicate for each item whether it makes them feel 'not anxious', 'a little bit anxious' or 'very anxious'.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Child Behaviour Checklist (CBCL)
The CBCL aims to quantify problem behavior and competences of children and adolescents. This questionnaire with 113 items (0-226, higher scores indicate more emotional and behavioral problems) is used in standard clinical care for routine outcome measuring. The questionnaire is filled out by the parents or caregivers of the child. Parents (both mothers and fathers) indicate on a 3-point scale whether the behavior was present in the last few months. The behavior can be classified according to different scales: Internalizing, Externalizing and other problems.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Teacher Report Form (TRF)
(C-)TRF is the teacher's version of the CBCL. The TRF has 113 items (0-226, higher scores indicate more emotional and behavioral problems) and is included in standard clinical care for routine outcome measuring. The questionnaire can be filled out by a teacher. The questionnaire gives insight in the child's behavior and competences at school as evaluated by the teacher.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Parenting burden questionnaire (OBVL)
With the Dutch OBVL, parents are asked to evaluate statements on how they experience their child and rearing, how they relate to their child and how they are feeling. On a 4-point scale parents indicate to what extend they agree with each statement (34 items, 34-136, higher scores indicate less parenting burden). The OBVL consists of 5 subscales: problems in the caregiver-child relationship, problems with upbringing, depressive moods, role restriction and health problems.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Family Accommodation Scale - Anxiety (FASA)
The questionnaire evaluates the level of family accommodation related to the child's anxiety and the level of distress the child experiences. The FASA consists of 13-questions that are scored on a 5-point Likert scale ranging from "never" to "daily". The first 9 items form the total accommodation scale (0-36, higher scores indicate more family accommodation). The subscale assessing the level of distress (5 items) is scored on a 5-point Likert scale ranging from "no" to "extreme." The FASA is included in standard clinical care for routine outcome measuring.
Measured: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Clinical global impression of outcome (CGI)
The CGI is a 2-item, clinician-rated scale used to assess global illness severity (1-7; higher score indicates more severity), over-all improvement (1-7, higher score indicates less improvement) from the start of treatment.
Measured: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
Outcome Rating Scale (ORS)
The Outcome Rating Scale (ORS) is used to monitor children's, young people and their families' or caregivers' feedback on therapeutic progress. The ORS is a 4-item session-by-session measure designed to assess areas of life functioning known to change as a result of therapeutic intervention. These areas include: personal or symptom distress, interpersonal well-being, social role and overall well-being (for each item 0-10; higher scores indicate better functioning)
Measured: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
Therapy evaluation: Visual Facial Anxiety Scale (VFAS)
Children are asked to indicate the level of anxiety, using a visual analogue scale, after completing a VR session and after individual therapy. The child can indicate whether they feel none, mild, mild - moderate, moderate, moderate - high or high anxiety.
Measured: During the intervention (up to 1 year; at the end of each VR session at home and at the end of each therapy session with therapist)
Qualitative interview child
A qualitative evaluation will be made after the intervention. During the interview the child will be asked to answer a few short semi-structured questions on their experiences with the VR homework exercises.
Measured: Immediately after intervention (up to 1 year)
Monthly VR evaluation
The researcher will schedule a 15-minute semi-structured interview to ask parents about their experiences during the VR sessions. The interview contains questions re-garding the practical use of the VR headset, how often parents have practised, the level of anxiety their child experiences while practicing and whether their child likes working with the VR homework exercises. Lastly, parents are asked whether there have been any special events that might have had an influence on the child's SM symptoms or the VR sessions.
Measured: During the intervention (once a month, up to 1 year)
Qualitative interview parents
A qualitative evaluation will be made after the intervention and after 3 months of follow-up. Both parents or caregivers are asked to share their experiences with the VR homework exercises and their vision on how the use of the VR homework exercises has helped their child to gain the confidence to speak at school.
Measured: Immediately after intervention (up to 1 year), and at follow-up (3 months after the end of the intervention)
Qualitative interview therapists
After the intervention, therapists are asked to share their perspective about the use of the VR homework exercises in addition to the standard treatment. They are asked to identify what factors, such as the relationship with parents or specific characteristics of the child/family contribute or hinder successful usage of the VR homework exercises.
Measured: Immediately after intervention (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Aug 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luuk Stapersma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luuk Stapersma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882629
- Sponsor's protocol ID
- NL86645.018.24
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Homework Exercises as an Add-On to Behavioral Therapy for Children With Selective Mutism
- ClinicalTrials.gov ID
- NCT06882629
- Acronym / sponsor ID
- NL86645.018.24
- Conditions
- Selective Mutism, Anxiety Disorder of Childhood
- Keywords
- Virtual reality, Virtual reality exposure therapy, Intervention, Treatment, Children, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Luuk StapersmaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Mar 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.
Selective mustism (SM) is an anxiety disorder that manifests in childhood. Children with Children with SM do not speak in certain social situations where this is expected of them. For example, a child may talk at home, but is afraid to speak at school. The goal of this clinical trial is to determine the efficacy of behavioral therapy for children with selective mutism (SM) combined with virtual reality (VR) homework exercises. Virtual Reality Exposure is an effective treatment for adults with anxiety disorders.
The main questions to answer are:
- Is behavioral therapy combined with VR homework exercises effective in the treatment of SM?
- Which familial factors contribute to a positive treatment outcome and homework adherence?
A single-case experimental design (SCED) will be used to evaluate the efficacy of the treatment. The child's speaking behavior at baseline will be compared to the child's speaking behavior in the different phases of the intervention.
Participants will:
- Follow individual therapy sessions at school.
- Practice with the VR homework exercises at least once a week.
- Parents and teachers will evaluate the child's speaking behavior.
Detailed description
The treatment in this study consists of behavioral therapy for SM (with the protocol 'Talking at school, a matter of doing') with the addition of the VR homework exercises. The protocol consists of 10 steps that help the child to gain confidence while speaking at school. The individual therapy sessions are provided at school. For every step of the protocol there are VR homework exercises available. Families receive a VR headset for the duration of the study. Parents are instructed to work on the VR homework exercises at least once a week and encouraged to work on the VR homework exercises several times a week. On average, treatment is approximately 25 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 'Speaking at school, a matter of doing' combined with VR homework exercisesBehavioral: 'Speaking at school, a matter of doing' combined with VR homework exercises |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child meets the DSM-5 criteria for SM (as a primary classification).
- The child is attending primary school.
- Referred to an academic center for Child and Adolescent Psychiatry (Levvel) for diagnosis and treatment of SM
- Psychiatric comorbidity is permitted, given that SM is the primary treatment target.
- Medication use is permitted, if stable for at least 4 weeks prior to the start of treatment.
Key exclusion criteria (7 listed)
- No participating parents.
- Parents do not have sufficient mastery of the Dutch language.
- Parents or child have an estimated IQ below 75.
- The child needs inpatient treatment.
- Children with a (medical) condition that is a contraindication for using a VR headset (epilepsy, claustrophobia, facial condition, sensitive vestibular system, panic attacks)
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 |
|---|---|---|
| 'Speaking at school, a matter of doing' combined with VR homework exercisesThe treatment in this study consists of behavioral therapy for selective mutism (with the protocol 'Speaking at school, a matter of doing') with the addition of the VR homework exercises. The protocol consists of 10 steps that help the child to gain confidence while speaking at school. For every treatment step there are VR homework exercises available. Families receive a VR headset for the duration of the study. Parents are instructed to work on the VR homework exercises at least once a week and encouraged to work on the VR homework exercises several times a week. | Behavioural | Intervention |
Primary outcome
SM symptoms (frequent measurement)
Time frame: During the baseline period (2 weeks), during the intervention phase (up to 1 year) and during follow-up (3 months after end of intervention phase), three times a week
Both parents and teachers are asked to report on SM symptoms. This is done by answering 9 yes/no questions on the child's speaking behavior and communication, including non-verbal communication, making sounds and conversing with others (more yes indicates more speaking behavior). The short assessment is specifically designed for this study in collaboration with experienced SM therapists and a statistician, specialized in SCED's.
SM symptoms (SMQ-NL)
Time frame: Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase, immediately after intervention (up to 4 months), at follow-up (3 months after end of intervention)
Evaluated by parents. The SMQ consists of 23 questions that are scored on a 4-point Likert scale ranging from "always" to "never." The symptom subscale consists of 17 questions (0-68; higher scores indicate more SM symptoms), that assess the severity of the symptoms across different situations (family, school and public situations). The second subscale indicates to what extend a child experiences problems due to not speaking in certain situations.
SM symptoms (Social context of speaking)
Time frame: Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase (up to 4 months), immediately after intervention, at follow-up (3 months after end of intervention)
The questionnaire consists of 16 questions assessing (0-64; higher scores indicate less SM symptoms) the social context of speaking assesses the severity of symptoms at school across different social situations (e.g. their own teacher, another teacher, in the classroom or in the presence of peers), speaking behaviour (e.g. whispering and functional speech) and its interference at school. Teachers are asked to evaluate how often child is showing different speaking behaviours and in which social context on a 4-point Likert scale. The questionnaire includes 8 questions that are based on the School Speech Questionnaire (SSQ). For the purpose of our study, the SSQ does not provide enough detail on the child's speaking behaviour, for that reason 8 more questions were included.
16 secondary outcomes
VR data
Time frame: During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)
VR completion
Time frame: During the intervention phase (once a week, up to 1 year)
VR immersion
Time frame: During the intervention phase (once a month, up to 1 year)
Structured Clinical Interview for DSM-5 Junior (SCID-5-Junior)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Fear Survey Schedule for Children - Revised (FSSC-R or in Dutch VAK 4-12)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Child Behaviour Checklist (CBCL)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Teacher Report Form (TRF)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Parenting burden questionnaire (OBVL)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Family Accommodation Scale - Anxiety (FASA)
Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
Clinical global impression of outcome (CGI)
Time frame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
Outcome Rating Scale (ORS)
Time frame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
Therapy evaluation: Visual Facial Anxiety Scale (VFAS)
Time frame: During the intervention (up to 1 year; at the end of each VR session at home and at the end of each therapy session with therapist)
Qualitative interview child
Time frame: Immediately after intervention (up to 1 year)
Monthly VR evaluation
Time frame: During the intervention (once a month, up to 1 year)
Qualitative interview parents
Time frame: Immediately after intervention (up to 1 year), and at follow-up (3 months after the end of the intervention)
Qualitative interview therapists
Time frame: Immediately after intervention (up to 1 year)
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 1 Oct 2026.
- Individual participant dataSharing planned: No
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Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Speaking at school, a matter of doing' combined with VR homework exercises in people with Selective Mutism and Anxiety Disorder of Childhood, run by Luuk Stapersma at 1 site in Netherlands.
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 5 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 1 Oct 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SM symptoms (frequent measurement) (time frame: During the baseline period (2 weeks), during the intervention phase (up to 1 year) and during follow-up (3 months after end of intervention phase), three times a week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.