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Cognitive Training for Post-Transplant Cognitive Impairment (cTAG Trial)
N/A
Recruiting
Led By Noha M Sharafeldin
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
cTAG Trial Summary
This trial will test whether it is possible to enroll patients in a study to improve their thinking skills after they have had a hematopoietic cell transplant, as well as whether patients are interested in learning about their genetic risk for cognitive impairment after the transplant.
Who is the study for?
This trial is for adults over 21 who had a bone marrow transplant at UAB, are 3-6 months post-transplant, and can use an internet-connected computer. It's not for those with neurological or major psychiatric disorders, significant sensory/motor issues, color blindness, or recent neuropsychological intervention.Check my eligibility
What is being tested?
The study tests if the Lumosity cognitive training program helps improve brain function in people who've had a bone marrow transplant. Participants will either start training right away or be placed on a waitlist (control group) to compare results.See study design
What are the potential side effects?
Since this trial involves cognitive exercises using Lumosity rather than medication, traditional side effects like you'd see with drugs aren't expected. However, participants may experience fatigue or frustration.
cTAG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.
Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
Secondary outcome measures
16-item survey to measure genetic factual knowledge at baseline
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake
+2 morecTAG Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The arm will begin the Lumosity program at enrollment in the study.
Group II: Wait List ControlActive Control1 Intervention
The arm will begin the Lumosity program 3 months after enrollment in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumosity
2016
N/A
~50
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,283,035 Total Patients Enrolled
Noha M SharafeldinPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of color blindness.I do not have a major neurological or psychiatric disorder, or significant hearing, vision, or movement issues.You have received help from a mental health professional in the last 6 months.I am 3 to 6 months post bone marrow transplant and not hospitalized.I am 21 years or older and had a stem cell transplant at UAB.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Wait List Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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