Brain Tumors Clinical Trial
Official title:
Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
While neurocognitive impairments in attention, memory and executive functioning are commonly
reported sequelae of childhood leukemia and brain tumors, studies have only recently begun
to examine the treatment of attention deficits in this population. Numerous studies have
examined the effectiveness of methylphenidate in the treatment of children with attention
deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for
improving attention and behavioral functioning in children with medical illnesses or brain
injury are less clear.
Patients will be randomized to receive one week of Metadate CD (a controlled release form of
methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Children's Cancer Research Fund United States |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of Methylphenidate on Neurocognitive Components | 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. | Week 1 and Week 2 | No |
Secondary | Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior | Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern. | Week 1 and Week 2 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Completed |
NCT02537106 -
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
|
N/A | |
Completed |
NCT01951950 -
Nicardipine vs Esmolol Craniotomy Emergence
|
Phase 1 | |
Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 | |
Completed |
NCT00873184 -
Study of Massage Therapy Within a Brain Tumor Setting
|
N/A | |
Active, not recruiting |
NCT01115777 -
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
|
||
Completed |
NCT00724191 -
Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
|
||
Completed |
NCT00003935 -
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
|
Phase 1 | |
Recruiting |
NCT04128306 -
Brain Areas of Time-To-Contact Perception: an Awake Surgery Study
|
N/A | |
Recruiting |
NCT05202899 -
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
|
Phase 4 | |
Completed |
NCT00707343 -
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00850278 -
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
|
N/A | |
Completed |
NCT00528437 -
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
|
Phase 2 | |
Terminated |
NCT00107471 -
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT00187174 -
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
|
Phase 1 | |
Completed |
NCT00135876 -
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
|
Phase 3 | |
Completed |
NCT00062478 -
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
|
Phase 2 | |
Completed |
NCT00241670 -
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
|
Phase 3 | |
Not yet recruiting |
NCT01445691 -
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
|
Phase 2 | |
Terminated |
NCT01018290 -
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
|
N/A |