StrokeT-ScEmo4ALLNCT06330298
Improving Social Cognition and Social Behaviour in Various Brain Disorders
A study testing Treatment social cognition and emotion regulation (T-ScEmo) in people with Stroke and Multiple Sclerosis, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Multiple Sclerosis, Brain Tumor
- What is being tested?
- Treatment social cognition and emotion regulation (T-ScEmo)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesNetherlands
- Study dates
- 31 May 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have social cognitive disorders that show by means of problems in emotion recognition, perspective taking, ToM, showing empathy, or behaviour.
- Patients should have a neurological disorder; stroke (including patients with subarachnoid haemorrhage), Multiple sclerosis (MS), both relapsing remitting, primary and secondary progressive variants, Brain tumours (meningioma's, low grade gliomas) and other categories of neurological disorders including brain damage: (i.e. infections (meningitis, encephalitis), post anoxic encephalopathy, adult survivors of childhood brain tumours).
- Patients should be aged between 18 and 75
- Patients should be in the chronic stage (> 6 months post-acute injuries) or their medical condition should be relatively stable (for patients with a slow progressive conditions), to be judged by the treating medical or psychological specialist, in order to be able to profit from treatment for a reasonable time period.
Who cannot join
- Serious neurodegenerative or psychiatric conditions (including addiction) interfering with treatment
- Incapacity to act, to be judged by the neuropsychologist and/or neurologist
- Serious cognitive problems (aphasia, neglect, amnesia, dementia) and/or serious behavioural problems (aggression, apathy) interfering with treatment, to be judged by neuropsychologist.
- Serious (other) medical conditions or physical inability hindering patients to come to the hospital/rehabilitation centre
- Not being available of a close other (life partner, family member, close friend) who can fill out the proxy questionnaires
- Not willing to give permission to send important/unexpected findings to the general practitioner.
- Unexpected progression of disease during the study can be a reason to exclude the patient
- Not sufficient command of the Dutch Language.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Deventer Hospital
Deventer, Overijssel, 7416SE
M.J.J. Gerritssen, dr.
- Recruiting
University Medical Center Groningen
Groningen, 9700VB
Amber Heegers, MSc., +3150 361 4666, a.heegers@umcg.nl
About this study
Official title: Improving Social Cognition and Social Behaviour in Various Brain Disorders.
Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.
Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).
Read more
Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.
It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.
- Conditions
- Stroke, Multiple Sclerosis, Brain Tumor
- Being tested
- Treatment social cognition and emotion regulation (T-ScEmo)
- Keywords
- Neuropsychology, Treatment, Social cognitive disorders, Emotion recognition, Theory of Mind, Social behaviour, Neurological disorders, Stroke, Brain tumour, Mulitple Sclerosis
- Medical subject headings
- Stroke, Multiple Sclerosis, Brain Neoplasms, Social Behavior, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment social cognition and emotion regulation (T-ScEmo)Behavioural
T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions
| Study group | Role | What they receive |
|---|---|---|
| Experimental condition: Receives T-ScEmo Treatment | Experimental | Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1 Receives: Behavioral: Treatment social cognition and emotion regulation (T-ScEmo) |
| Waiting list group: Will be on waiting list instead of treatment | No intervention | Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social behaviour examined by proxy
The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.
Measured: Through study completion, an average of 8 to 10 months
Secondary outcomes (18)
Social cognition: Emotion recognition as assessed using the Eckman-60 faces test
Performance on neuropsychological test measuring emotion recognition; Eckman-60 faces test (EFT). This test has a range between 0 and 60. A higher outcome means a better performance.
Measured: Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Happé cartoons test
Performance on neuropsychological test measuring Theory of Mind; Happé cartoons test. This test has a range between 0 and 36. A higher outcome means a better performance.
Measured: Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Faux Pas test
Performance on neuropsychological test measuring Theory of Mind: Faux Pas test. This test has a range between 0 and 10. A higher outcome means a better performance.
Measured: Through study completion, an average of 8 to 10 months
Social cognition: assessed using the Hailing Sentence Completion Test
Performance on neuropsychological test measuring inhibition; Hailing Sentence Completion Test. This test has a range between 1 and 10. A higher outcome means a better performance.
Measured: Through study completion, an average of 8 to 10 months
Demographic information
Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.
Measured: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.
Self-reated social behaviour will be measured with a self rating on the Dysexecutive questionnaire Social Scales. Measuring the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. This scale has a range between 0 and 80. A higher outcome means more complaints.
Measured: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Interpersonal Reactivity Index
Self-rated social behavior will be measured with the Interpersonal Reactivity Index (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.
Measured: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales
Self-rated social behavior will be measured with The Dutch version of the BAFQ social scales (BAFQ-SOC). Moreover, patients answer if they have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.
Measured: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index
Proxy-rated social behavior will be measured with the Interpersonal Reactivity Index, proxy version (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.
Measured: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale
Proxy-rated social behavior will be measured with the Socioemotional Dysfunction Scale (SDS). This scale has a range between 40 and 200. A higher outcome means more complaints.
Measured: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales
Proxy-rated social behavior will be measured with the Dutch version of the BAFQ social scales, proxy version (BAFQ-SOC). Moreover, proxies answer if patients have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.
Measured: Through study completion, an average of 8 to 10 months
Alexithymia
The presence of alexithymia will be measured with a self-rating on the Toronto Alexithymia Scale (TAS-20). This scale has a range between 20 and 100. A higher outcome means more complaints.
Measured: Through study completion, an average of 8 to 10 months
Life satisfaction
Quality of life will be determined with a self-rating on the Life Satisfaction Questionnaire (LSQ-9). This scale has a range between 6 and 54. A higher outcome means a higher subjective quality of life.
Measured: Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation
The level of societal participation will be measured with the scores on the Utrecht Scale for Evaluation of Rehabilitation (USER-P). A higher outcome means higher participation rate.
Measured: Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Impact on Participation and Autonomy scale
The level of societal participation will be measured with the Impact on Participation and Autonomy (IPA). A higher outcome means lower participation rate.
Measured: Through study completion, an average of 8 to 10 months
Mood and anxiety
The level of mood and anxiety will be obtained with the Hospital Anxiety and Depression Scale (HADS). This scale has a range between 0 and 42. A higher outcome means more complaints.
Measured: Through study completion, an average of 8 to 10 months
Caregiving burden
The extend to which proxies experience a burden in taking care of the patient wil be measured with the Zarit burden interview. This scale has a range between 0 and 48. A higher outcome means more burden.
Measured: Through study completion, an average of 8 to 10 months
Goal attainment
The extent to which patients in the treatment condition improve on their set treatment goals will be measured with the Goal Attainment Scale (GAS). This scale has a range between 1 and 10. A higher outcome means better attainment.
Measured: Through study completion, an average of 8 to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start31 May 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (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 University Medical Center GroningenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment Waiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1 TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition. In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.M. Spikman, Prof. Dr., Principal investigator, Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330298
- Sponsor's protocol ID
- 202000479
- Acronym
- T-ScEmo4ALL
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heegers A, Rakers SE, van Twillert S, Moulaert VRM, Gerritsen MMJ, van der Naalt J, Spikman JM, Westerhof-Evers HJ. Social Cognitive Treatment (T-ScEmo) for Various Neurological Patient Groups: Study Rationale and Protocol for a Randomized Control Trial (T-ScEmo4ALL). BMC Neurol. 2025 Mar 27;25(1):129. doi: 10.1186/s12883-025-04125-4.
PubMed 40148852
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Cognition and Social Behaviour in Various Brain Disorders.
- ClinicalTrials.gov ID
- NCT06330298
- Acronym / sponsor ID
- T-ScEmo4ALL / 202000479
- Conditions
- Stroke, Multiple Sclerosis, Brain Tumor
- Keywords
- Neuropsychology, Treatment, Social cognitive disorders, Emotion recognition, Theory of Mind, Social behaviour, Neurological disorders, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 26 Mar 2024 (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.
Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.
Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).
Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.
It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Experimental condition T0, baseline measurement at point of inclusion (at least > 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment Waiting list condition T0, baseline measurement at point of inclusion (at least > 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1 TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition. In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care.
| Arm | Type | Receives |
|---|---|---|
| Experimental condition: Receives T-ScEmo Treatment | Experimental | Behavioral: Treatment social cognition and emotion regulation (T-ScEmo)Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1 |
| Waiting list group: Will be on waiting list instead of treatment | No intervention | –Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients should have social cognitive disorders that show by means of problems in emotion recognition, perspective taking, ToM, showing empathy, or behaviour.
- Patients should have a neurological disorder; stroke (including patients with subarachnoid haemorrhage), Multiple sclerosis (MS), both relapsing remitting, primary and secondary progressive variants, Brain tumours (meningioma's, low grade gliomas) and other categories of neurological disorders including brain damage: (i.e. infections (meningitis, encephalitis), post anoxic encephalopathy, adult survivors of childhood brain tumours).
- Patients should be aged between 18 and 75
- Patients should be in the chronic stage (> 6 months post-acute injuries) or their medical condition should be relatively stable (for patients with a slow progressive conditions), to be judged by the treating medical or psychological specialist, in order to be able to profit from treatment for a reasonable time period.
Key exclusion criteria (8 listed)
- Serious neurodegenerative or psychiatric conditions (including addiction) interfering with treatment
- Incapacity to act, to be judged by the neuropsychologist and/or neurologist
- Serious cognitive problems (aphasia, neglect, amnesia, dementia) and/or serious behavioural problems (aggression, apathy) interfering with treatment, to be judged by neuropsychologist.
- Serious (other) medical conditions or physical inability hindering patients to come to the hospital/rehabilitation centre
- Not being available of a close other (life partner, family member, close friend) who can fill out the proxy questionnaires
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 |
|---|---|---|
| Treatment social cognition and emotion regulation (T-ScEmo)T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions | Behavioural | Experimental condition: Receives T-ScEmo Treatment |
Primary outcome
Change in social behaviour examined by proxy
Time frame: Through study completion, an average of 8 to 10 months
The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.
18 secondary outcomes
Social cognition: Emotion recognition as assessed using the Eckman-60 faces test
Time frame: Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Happé cartoons test
Time frame: Through study completion, an average of 8 to 10 months
Social cognition: Theory of Mind as assessed using the Faux Pas test
Time frame: Through study completion, an average of 8 to 10 months
Social cognition: assessed using the Hailing Sentence Completion Test
Time frame: Through study completion, an average of 8 to 10 months
Demographic information
Time frame: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales.
Time frame: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using the Interpersonal Reactivity Index
Time frame: Through study completion, an average of 8 to 10 months
Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales
Time frame: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index
Time frame: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale
Time frame: Through study completion, an average of 8 to 10 months
Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales
Time frame: Through study completion, an average of 8 to 10 months
Alexithymia
Time frame: Through study completion, an average of 8 to 10 months
Life satisfaction
Time frame: Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation
Time frame: Through study completion, an average of 8 to 10 months
(Social) participation as assessed using the Impact on Participation and Autonomy scale
Time frame: Through study completion, an average of 8 to 10 months
Mood and anxiety
Time frame: Through study completion, an average of 8 to 10 months
Caregiving burden
Time frame: Through study completion, an average of 8 to 10 months
Goal attainment
Time frame: Through study completion, an average of 8 to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 40148852Heegers A, Rakers SE, van Twillert S, Moulaert VRM, Gerritsen MMJ, van der Naalt J, Spikman JM, Westerhof-Evers HJ. Social Cognitive Treatment (T-ScEmo) for Various Neurological Patient Groups: Study Rationale and Protocol for a Randomized Control Trial (T-ScEmo4ALL). BMC Neurol. 2025 Mar 27;25(1):129. doi: 10.1186/s12883-025-04125-4.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
J.M. Spikman, Prof. Dr. principal investigator
Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment social cognition and emotion regulation (T-ScEmo) in people with Stroke and Multiple Sclerosis, run by University Medical Center Groningen at 2 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A Heegers, MSc. (+31503614666, a.heegers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social behaviour examined by proxy (time frame: Through study completion, an average of 8 to 10 months). 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 NCT06330298, 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 16 Apr 2024.