Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1

Learn more about:
Related Clinical Trial
Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1 Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1 Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Systematically Assessing Changes in Plexiform Neurofibroma Related Disfigurement From Photographs of Subjects With Neurofibromatosis Type 1 on a Phase 2 Clinical Trial Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1 Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1 Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN) Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial Antioxidant Therapy With N-acetylcysteine for Children With Neurofibromatosis Type 1 Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1 A Long-term Study of NPC-12G Gel in Neurofibromatosis Type I NFX-179 Topical Gel Treatment in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Analysis of Data Collected From Individuals Administered Neurobehavioral Assessments Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas Medical Treatment of “High-Risk” Neurofibromas Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1 Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (PNs) Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas Treatment of NF1-related Plexiform Neurofibroma With Trametinib Subtle Myocardial Deformation Abnormalities in Asymptomatic Nf-1 Patients R115777 to Treat Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas Pirfenidone in Children and Young Adults With Neurofibromatosis Type I and Progressive Plexiform Neurofibromas Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas Ranibizumab for Neurofibromas Associated With Neurofibromatosis 1 AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma and/or Neurofibroma Near the Spine MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Study of Sutent®/Sunitinib (SU11248) in Subjects With NF-1 Plexiform Neurofibromas Neurofibromatosis Type 1 Brain Tumor Genetic Risk Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I Reliability of Functional Outcome Measures in Neurofibromatosis 1 Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults Medication Adherence in Children, Adolescents and Adults With Neurofibromatosis Type 1 (NF1) on Clinical Treatment Trials Targeting the Mechanisms Underlying Cutaneous Neurofibroma Formation in NF1: A Clinical Translational Approach. Sorafenib to Treat Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) Quality of Friendships in Children With Neurofibromatosis Study of Disease Severity in Adults With Neurofibromatosis Type 1 (NF1) MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas Interventions for Reading Disabilities in NF1 Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1 Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain Neurobiology and Treatment of Reading Disability in NF-1 From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1 Vitamin D Supplementation for Adults With Neurofibromatosis Type 1 (NF1) Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1 Analysis of Plasma for Diagnosis and Follow-up of Neurofibromatosis Type 1 Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms MicroRNAs in Patients With Neurofibromatosis Type 1 Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas Stem Cells in NF1 Patients With Tumors of the Central Nervous System Function of the Pigment Epithelium in Patients With Type 1 Neurofibromatosis NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1) Internet Support Group for Parents of a Child With Neurofibromatosis Type 1 Reading Disability in Children With NF1 Multi-center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) Patients Functional Imaging and Reading Deficit in Children With NF1 Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1 Effect of Lamotrigine on Cognition in NF1 A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1 Neurofibromatosis Type 1 (NF1) and Tibial Dysplasia Non-invasive Stimulation in Neurofibromatosis Type 1 Modifying Genes in Neurofibromatosis 1 Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1 Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1 Spinal Abnormalities in Neurofibromatosis Type 1 (NF1) Neurofibromatosis Type 1 Patient Registry Frameshift Peptides of Children With NF1 Prevalence of Constitutional Mismatch-repair Deficiency Among Suspected Neurofibromatosis Type 1/Legius Syndrome Children Without a Malignancy and Without a NF1 or SPRED1 Mutation How Neurofibromatosis Type 1 (NF1) Affects Schoolwork and Self-Esteem

Brief Title

Efficacy of Computerized Cognitive Training and Stimulant Medication in Neurofibromatosis Type 1

Official Title

Multimodal Intervention Trial for Cognitive Deficits in Neurofibromatosis Type 1: Efficacy of Computerized Cognitive Training and Stimulant Medication

Brief Summary

      The main objective of the study is to assess the efficacy of a home-based, computerized
      cognitive training (CT) program, called CogmedRM, targeted to improve working memory in
      children with NF1 and working memory difficulties. This is a Phase II randomized parallel
      group controlled clinical trial comparing two interventions on cognitive outcomes.
      Participants will be stratified by stimulant medication use and randomized equally between
      the two interventions within stratum. Participants will be in the study for to 11 weeks.
    

Detailed Description

      Cognitive deficits are the most important cause of long-term dysfunction in patients with
      Neurofibromatosis type 1 (NF1). Among the most frequently-occurring difficulties are problems
      with attention, working memory (WM), and executive functioning (EF). Remediation and
      interventions to improve those deficits have the potential to impact the quality of life and
      long-term prognosis in this population. Cognitive training (CT) programs have increasingly
      been used independently or in conjunction with pharmacotherapies in children with accidental
      or disease-related brain injury. CogmedRM is both the most well-researched and widely-used CT
      program for remediation of WM deficits. Results from numerous randomized, controlled trials
      conducted with a variety of pediatric and adult patient populations generally show that
      CogmedRM training is associated with robust gains in performance-based WM scores over the
      short term, with some variability in improvement across disease groups. A single arm pilot
      study of CogmedRM in a sample of children with NF1 conducted at Children's National Medical
      Center has shown that the approach is likely feasible and acceptable to families.

      Because many children with NF1 are treated with stimulant medications, and there is
      biological evidence that both CT and Methylphenidate act on dopaminergic systems, the
      investigators are also interested in examining whether or not there is a synergistic effect
      between these widely available and safe interventions. Thus, the aim is to assess the
      efficacy of a home-based, computerized cognitive training (CT) program in a sample of 90
      children aged 8-16 with NF1 and working memory difficulties. This study will be conducted
      over the span of four years. If the participant qualifies following baseline testing, he/she
      will be randomized to the intervention, CogmedRM, or the active control condition, MobyMax
      (an online reading program). The participant will have 5-9 weeks to complete the program and
      will have follow-up testing 2 weeks after finishing the program. If CT, either singly or in
      combination with stimulant medication, can be shown to be efficacious in a sample of NF1
      pediatric patients at high risk for neurocognitive deficits, this intervention plan could be
      rapidly translated to clinical practice.
    


Study Type

Interventional


Primary Outcome

Change in CogState One-back subtest

Secondary Outcome

 Change in Attention Deficit Hyperactive Disorder- Rating Scale

Condition

Neurofibromatosis Type 1

Intervention

CogmedRM

Study Arms / Comparison Groups

 Cogmed
Description:  Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

130

Start Date

May 2016

Completion Date

September 2021

Primary Completion Date

September 2021

Eligibility Criteria

        Inclusion Criteria:

          1. 8-16 years old at time of screening

          2. NF1 Diagnosis based on National Institute of Health (NIH) criteria

          3. Has an identified caregiver who is willing and able to oversee the training practice
             during the intervention period

          4. Has access to a telephone and phone number where they can be reached

          5. Both patient and caregiver have reading, speaking, and listening comprehension of
             English

          6. Treated with a stable dose of stimulant medication for at least the last 30 days and
             not planning to change the dose during study participation or receiving no stimulant
             medications for at least the last 30 days and not planning to initiate a trial of
             stimulant medications for the duration of the study.

          7. >1 Standard Deviation (SD) below the mean on the WISC-V-Integrated Spatial Span
             Backwards task or a Spatial Span Backwards score >1 SD below the participant's
             estimated IQ.

        Exclusion Criteria:

          1. Full scale IQ<70, as estimated by WASI-II (Block Design, Vocabulary, Matrix Reasoning,
             Similarities).

             Note: In cases where there is a statistically significant difference between verbal IQ
             and performance IQ (.05 level as determined by the WASI-II manual), participants will
             be eligible if at least one of these quotients is 70 or above

          2. Current treatment for intracranial lesions, progressive tumors as per MRI evaluation
             or treatment with chemotherapy within the past 6 months

          3. A motor, visual, or auditory handicap that prevents computer use
      

Gender

All

Ages

8 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Kristina Hardy, PhD, 202-476-2514, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02944032

Organization ID

00007343


Responsible Party

Sponsor-Investigator

Study Sponsor

Kristina Hardy

Collaborators

 Children's National Health System

Study Sponsor

Kristina Hardy, PhD, Principal Investigator, Children's National Health System


Verification Date

March 2021