Clinical trial Recruiting at 1 site Observational Ages 20 to 75

Investigating fatigue and cognitive dysfunction in patients after stem cell transplantation

Official title: Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan

Run by Karolinska Institutet · NCT06363396 · Data updated 2026-11-12

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 typeObservational
Ages20 Years to 75 Years
SexAll
Enrollment30 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations1 site (Stockholm)
StatusRecruiting
StartedFebruary 22, 2024
Main results expectedFebruary 22, 2026
Study endsFebruary 22, 2027
Registry record updatedApril 12, 2024
Trial IDNCT06363396 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who are 1-5 years post-allogeneic stem cell transplantation without known CNS disorders or psychiatric disturbances.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have suggested distinct biological profiles related to fatigue and cognitive dysfunction, indicating potential for success in this area.

Who can join: the full rules

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 it's running

  • Karolinska
    Stockholm, Sweden
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.