Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06817395

Conditions

Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Immune Thrombocytopenia

Study ID

NCT06817395

Start date

Sep 15, 2024

Status verified date

Feb, 2025

Completion date

Sep 15, 2028

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults with chronic or persistent ITP

Primary outcome measure

  • Impairment of fluid cognition [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Debbie Jiang, MD

617-724-4000dcjiang@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Debbie C Jiang, MD

617-724-4000dcjiang@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Keywords

  • Cognitive impairment
  • Immune thrombocytopenia
  • ITP
  • Quality of life
  • Cognitive dysfunction
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-02-10.