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Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer


N/A
8 Years
17 Years
Not Enrolling
Both
ALL, Childhood, Leukemia, Lymphoblastic, Leukemia, Lymphoblastic, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Leukemia, Lymphocytic, Acute, Leukemia, Lymphocytic, Acute, L1, Leukemia, Lymphocytic, Acute, L2, Lymphoblastic Leukemia, Lymphoblastic Leukemia, Acute, Lymphoblastic Leukemia, Acute, Childhood, Lymphoblastic Leukemia, Acute, L1, Lymphoblastic Leukemia, Acute, L2, Lymphoblastic Lymphoma, Lymphocytic Leukemia, Acute, Lymphocytic Leukemia, L1, Lymphocytic Leukemia, L2, Brain Tumors, Cancer of the Brain, Cancer of Brain, Malignant Primary Brain Tumors, Brain Neoplasms, Malignant

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Trial Information

Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Effectiveness of Methylphenidate on Neurocognitive Components

Outcome Description:

Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.

Outcome Time Frame:

Week 1 and Week 2

Safety Issue:

No

Principal Investigator

Alicia Kunin-Batson, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2009NTLS075

NCT ID:

NCT01100658

Start Date:

May 2010

Completion Date:

November 2010

Related Keywords:

  • ALL, Childhood
  • Leukemia, Lymphoblastic
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Lymphoblastic, Acute, L1
  • Leukemia, Lymphoblastic, Acute, L2
  • Leukemia, Lymphoblastic, Acute, Philadelphia-positive
  • Leukemia, Lymphocytic, Acute
  • Leukemia, Lymphocytic, Acute, L1
  • Leukemia, Lymphocytic, Acute, L2
  • Lymphoblastic Leukemia
  • Lymphoblastic Leukemia, Acute
  • Lymphoblastic Leukemia, Acute, Childhood
  • Lymphoblastic Leukemia, Acute, L1
  • Lymphoblastic Leukemia, Acute, L2
  • Lymphoblastic Lymphoma
  • Lymphocytic Leukemia, Acute
  • Lymphocytic Leukemia, L1
  • Lymphocytic Leukemia, L2
  • Brain Tumors
  • Cancer of the Brain
  • Cancer of Brain
  • Malignant Primary Brain Tumors
  • Brain Neoplasms, Malignant
  • Brain Neoplasms
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Acute Disease

Name

Location
University of Minnesota Medical Center, Fairview Minneapolis, Minnesota  55455