Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Last updated: February 4, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

White Cell Disorders

Thrombocytopenia And Thrombocytopenia Prevention

Treatment

N/A

Clinical Study ID

NCT06817395
2024P000181
  • Ages > 18
  • All Genders

Study Summary

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is:

Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery?

To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged ≥ 18 years

  • A clinical diagnosis of persistent or chronic ITP, as defined by a history ofplatelet counts <50 x 109/L on two occasions in the preceding 3 to 12 months or >12months, respectively, and documented response to at least 1 prior ITP-directedtherapy. ITP-directed therapies include corticosteroids, intravenous immuneglobulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, andfostamatinib. Other qualifying agents used for the treatment of ITP are permissiblewith approval of the principal investigator.

  • Ability to follow instructions in English.

Exclusion

Exclusion Criteria:

  • Pre-existing diagnosis of cognitive impairment from dementia, stroke, or otherneurologic 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 surgicaltreatment, 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 completeneurocognitive testing via a virtual platform.

Study Design

Total Participants: 100
Study Start date:
September 15, 2024
Estimated Completion Date:
September 15, 2028

Study Description

This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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