Clinical Trials Logo

Clinical Trial Summary

Intellectual impairment, particularly working memory deficits are a significant cause of morbidity in children with Neurofibromatosis type (NF1) with long-term implications on academic and occupational functioning. Whilst significant discoveries have been made in Nf1 animal models in trying to find treatments for these conditions, human translational studies have not been successful. This mechanistic experimental study will investigate the neural mechanisms underlying working memory deficits in NF1. In particular, we will investigate how individual differences in inhibitory neurotransmitter GABA relate to performance on working memory tests. Further, we will investigate the use of a novel, experimental intervention called transcranial Direct Current Stimulation (tDCS);known to modulate GABA. Using a randomized, crossover design in a cohort of 30 adolescents aged 11-17 years, we will apply real or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). State-of-art real time imaging techniques such as Magnetic Resonance Spectroscopy (MRS) and task based functional MRI (fMRI) will be used to investigate the effect of tDCS on GABA concentration, changes in functional plasticity and working memory. We expect that results from this study will help elucidate the neural mechanisms underlying working memory deficits in people with NF1 and show biologic activity for a novel, low-cost intervention that can be used for cognitive remediation in NF1. This kind of focused mechanism trial method is a highly promising approach to understanding the complex neural system pathology in a multifactorial neurodevelopmental condition like NF1.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04991428
Study type Interventional
Source University of Manchester
Contact
Status Completed
Phase N/A
Start date February 22, 2019
Completion date February 19, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01362803 - AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors Phase 1/Phase 2
Completed NCT00352599 - Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1) Phase 1
Completed NCT05005845 - NFX-179 Topical Gel Treatment for Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF) Phase 2
Completed NCT03531814 - Medication Adherence in Children, Adolescents and Adults With Neurofibromatosis Type 1(NF1) on Clinical Treatment Trials N/A
Completed NCT00846430 - Medical Treatment of "High-Risk" Neurofibromas Phase 2
Completed NCT03433183 - SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors Phase 2
Recruiting NCT05331105 - HL-085 in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas Phase 2
Completed NCT03310996 - Non-invasive Stimulation in Neurofibromatosis Type 1 N/A
Recruiting NCT03406208 - Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing N/A
Not yet recruiting NCT05849662 - A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia Phase 1/Phase 2
Recruiting NCT04750928 - Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas Phase 1/Phase 2
Not yet recruiting NCT06262113 - A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1 N/A
Active, not recruiting NCT04924608 - Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Phase 3
Recruiting NCT02544022 - Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
Recruiting NCT04941027 - Evaluating Genetic Modifiers of Cutaneous Neurofibromas in Adults With Neurofibromatosis Type 1
Completed NCT02153931 - Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
Completed NCT05196854 - Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1 N/A
Active, not recruiting NCT01650142 - Modifying Genes in Neurofibromatosis 1 N/A
Not yet recruiting NCT06222203 - Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)
Completed NCT05377008 - Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1 N/A