Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT01100658
Eligibility Criteria:
Inclusion Criteria:
Initial Screening and Registration
* Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.
* Proficient in English
* Have given informed consent (assent)
After Initial Screening
* Have evidence of attention impairment based on parent report of attention deficit (\> and = 75% on attention deficit hyperactivity disorder \[ADHD\] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale \[Conners Parent Rating Scale\] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA)
* Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) \>55.
Exclusion Criteria:
* Have optic pathway gliomas and/or neurofibromatosis
* Diagnosed with ADD/ADHD prior to their cancer diagnosis
* Currently taking antidepressants or antipsychotics
* Currently being treated with stimulant medication
* Blind
* Have glaucoma
* Have a family or personal history of motor or phonic tics or Tourette syndrome
* Have seizures not controlled by antiepileptic drugs
* Taking an MAO-inhibitor
* Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT01100658
Study Brief:
Protocol Section:
NCT01100658