Investigating fatigue and cognitive dysfunction in patients after stem cell transplantation
Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan
Karolinska Institutet · NCT06363396
This study is trying to see if there are specific signs in the blood and spinal fluid that can help identify fatigue and thinking problems in patients who have had stem cell transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06363396 on ClinicalTrials.gov |
What this trial studies
This observational study follows patients who have undergone allogeneic stem cell transplantation to systematically measure fatigue and cognitive impairment using international standards. The study aims to validate previous findings regarding distinct mRNA and proteomic profiles that differentiate fatigued from non-fatigued patients. Researchers will analyze blood and cerebrospinal fluid samples to identify potential biomarkers for cognitive dysfunction and fatigue, employing advanced techniques such as mass spectrometry and Olink technology. Additionally, neurocognitive testing will be conducted to predict which patients may develop these conditions, contributing to a better understanding of their pathophysiology.
Who should consider this trial
Good fit: Ideal candidates are patients who are 1-5 years post-allogeneic stem cell transplantation without known CNS disorders or psychiatric disturbances.
Not a fit: Patients with prior CNS irradiation, known neurological or psychiatric disorders, or those less than 1 year or more than 5 years post-transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of fatigue and cognitive dysfunction in patients post-transplant.
How similar studies have performed: Previous studies have suggested distinct biological profiles related to fatigue and cognitive dysfunction, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * status 1-5 years after HSCT * no known CNS disorders or psychiatric disturbances Exclusion Criteria: * prior TBI or CNS irradiation / intrathecal therapy * known neurological or psychiatric disorder * time less then 1 year or over 5 years after transplantation
Where this trial is running
Stockholm
- Karolinska — Stockholm, Sweden (RECRUITING)
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.
Conditions: Fatigue, Cognitive Dysfunction