NCT06330298: T-ScEmo4ALL

Improving Social Cognition and Social Behaviour in Various Brain Disorders

Recruiting now NA Last updated 16 April 2024

What this trial tests

NA trial testing Treatment social cognition and emotion regulation (T-ScEmo) in Stroke in 84 participants. Currently enrolling.

Timeline

31 May 2021

Primary endpoint
31 January 2025

31 January 2025

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	84
Start date	31 May 2021
Primary completion	31 January 2025
Estimated completion	31 January 2025
Sites	2 locations across Netherlands

Drugs / interventions tested

• Treatment social cognition and emotion regulation (T-ScEmo)

Conditions studied

• Stroke — all drugs for Stroke →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Brain Tumor — all drugs for Brain Tumor →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 75, any sex, with Stroke or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Social Cognitive Treatment (T-ScEmo) for Various Neurological Patient Groups: Study Rationale and Protocol for a Randomized Control Trial (T-ScEmo4ALL).
   Heegers A, Rakers SE, van Twillert S, Moulaert VRM, et al · · 2025 · PMID 40148852 · DOI 10.1186/s12883-025-04125-4