Cognitive symptoms are common in immune thrombocytopenia and associate with autonomic symptom burden.
James Frith, Shirley Watson, Paula H B Bolton Maggs...
https://pubmed.ncbi.nlm.nih.gov/22044734Actively Recruiting
Age: 18Years +
All Genders
ID06817395
Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)
Led by Massachusetts General Hospital · Updated on 2025-02-10
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Platelet Disorder Support Association (PDSA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating cognitive difficulties in adults with persistent or chronic immune thrombocytopenia (ITP), a condition where patients often report problems with attention and memory. The main goal is to determine whether people with ITP show signs of cognitive impairment using a set of cognitive tests. The study also looks at how cognitive problems relate to quality of life, fatigue, mood, and disease history in ITP patients. This is a long-term observational study where participants complete neurocognitive testing through the NIH Toolbox Cognition Battery. They will also fill out surveys about their quality of life, fatigue, mood, and cognitive symptoms. Clinical history and background information will be collected through enrollment surveys and medical record reviews. The study aims to describe how common cognitive impairment is in ITP, identify related risk factors, and assess the ability to track cognitive changes over time. Participants will take cognitive tests and complete various surveys at enrollment and possibly over a two-year period to monitor changes. Researchers will evaluate fluid cognition as the primary outcome and study the feasibility of repeated cognitive assessments. The study includes detailed data collection on patient-reported outcomes and clinical characteristics. Participation involves survey completion, cognitive testing, and chart reviews to provide a comprehensive understanding of cognition in ITP.
CONDITIONS
Brief Title
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 2 18 years
- Clinical diagnosis of persistent or chronic immune thrombocytopenia (ITP) with platelet counts <50 x 10^9/L on two occasions in the past 3 to 12 months or over 12 months
- Documented response to at least one prior ITP-directed therapy including corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, or fostamatinib
- Ability to follow instructions in English
You will not qualify if you...
- Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease
- Active psychiatric disorder such as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse
- Active malignancy requiring or likely to require chemotherapy or surgery, except for non-melanoma skin cancer
- Brain tumor or cranial surgery within the past year
- Significant hearing or vision impairment that would prevent completing neurocognitive testing via a virtual platform
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or in-person) for eligibility assessment
Diagnostic Evaluation
Duration - Baseline assessment at enrollment
Participants complete neurocognitive testing and surveys to assess cognitive function, quality of life, fatigue, and depression.
1 baseline visit (virtual or in-person) for testing and surveys
Long-term Monitoring
Duration - Up to 2 years of follow-up
Participants undergo repeated neurocognitive assessments over time to observe changes in cognition.
Periodic visits for longitudinal cognitive testing and surveys over 2 years
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
D
Debbie Jiang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Fatigue and cognitive impairment in immune thrombocytopenic purpura remain stable over time: short report from a longitudinal study.
Eleanor Mitchell, James Frith, Julia Newton
https://pubmed.ncbi.nlm.nih.gov/31119732Cognitive impairment among patients with chronic immune thrombocytopenia.
David J Kuter, Umer Khan, Paul Maruff...
https://pubmed.ncbi.nlm.nih.gov/38724473