Evaluating cognitive dysfunction in patients with immune thrombocytopenia

Is this trial a fit for you?

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 aims to assess cognitive impairment in adults with chronic and persistent immune thrombocytopenia (ITP) using a cognitive function test battery. Participants will undergo neurocognitive testing and complete surveys regarding their quality of life, fatigue, depression, and cognitive symptoms. The study seeks to determine the prevalence and extent of cognitive dysfunction in ITP patients and explore associated risk factors, as well as the feasibility of longitudinal cognitive testing over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged ≥ 18 years
* A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \<50 x 109/L on two occasions in the preceding 3 to 12 months or \>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.
* Ability to follow instructions in English.

Exclusion Criteria:

* Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease.
* Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse.
* Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer.
* Brain tumor or cranial surgery within the past year.
* Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Debbie Jiang, MD
• Email: dcjiang@mgh.harvard.edu
• Phone: 617-724-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Daratumumab versus rituximab for adult primary immune thrombocytopenia

  This trial will test whether daratumumab (an anti‑CD38 antibody) works better than rituximab for adults with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07297563

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.