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Search / Trial NCT06817395

Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 4, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cognitive Impairment Immune Thrombocytopenia Itp Quality Of Life Cognitive Dysfunction Cognition

ClinConnect Summary

This clinical trial is studying how immune thrombocytopenia (ITP), a condition that affects your blood platelets, might impact your thinking and memory. Many people with ITP report having trouble with attention and memory, and this study aims to find out if these difficulties are real and how severe they are. Participants will take tests to assess their cognitive function (which means how well they think and remember) and complete surveys about their quality of life, fatigue, mood, and cognitive symptoms.

To be eligible for the study, you need to be an adult aged 18 or older with a diagnosis of chronic or persistent ITP. This means you should have a history of low platelet counts and have tried at least one treatment for ITP. However, if you have a history of severe memory issues, certain psychiatric disorders, or recent serious health problems like cancer or major surgeries, you might not be able to participate. If you join the study, you can expect to share your experiences and undergo some tests that could help improve understanding of ITP and its effects.

Gender

ALL

Eligibility criteria

  • 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.

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported