Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1

Neurofibromatosis 1 Clinical Trial

Official title:

Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991428
• Other study ID #: 18/NW/0762
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: July 2021
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Meets National Institute of Health NF1 diagnostic criteria

2. Children aged 11-17 years

3. Written informed consent/assent

Exclusion Criteria:

1. No history of intracranial pathology other than asymptomatic optic pathway glioma or other asymptomatic and untreated NF1-associated white matter lesion

2. No history of epilepsy or any major mental illness

3. No MRI contraindications.

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1

Intervention

Other:
• Transcranial direct current stimulation
tDCS is a form of non-invasive brain stimulation. tDCS is an established research tool for non-invasive modulation of neuroplasticity. It uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential. Anodal tDCS has been shown to increase cortical excitability, reduce regional levels of GABA enhance LTP and synaptic plasticity.

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corsi Block task	memory span task	immediately after the intervention