Improving social cognition and behavior in patients with brain disorders
Improving Social Cognition and Social Behaviour in Various Brain Disorders.
This study is testing a new program to help people with brain disorders improve their social skills and emotional understanding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 2 sites (Deventer, Overijssel and 1 other locations) |
| Trial ID | NCT06330298 on ClinicalTrials.gov |
What this trial studies
This study focuses on enhancing social cognition and emotional regulation in patients suffering from neurological disorders such as stroke, multiple sclerosis, and brain tumors. It employs a novel intervention called T-ScEmo, which aims to improve skills like emotion recognition, perspective taking, and empathy. The treatment is designed for individuals who have chronic social cognitive disorders and are in a stable condition, allowing them to benefit from the intervention over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with chronic social cognitive disorders stemming from neurological conditions.
Not a fit: Patients with acute neurological conditions or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and social functioning for patients with neurological disorders.
How similar studies have performed: Previous studies have shown success in improving social cognition in traumatic brain injury, suggesting potential for this approach in other neurological disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Deventer, Overijssel and 1 other locations
- Deventer Hospital — Deventer, Overijssel, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: J.M. Spikman, Prof. Dr. — Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
- Study coordinator: A Heegers, MSc.
- Email: a.heegers@umcg.nl
- Phone: +31503614666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.