Non-invasive Stimulation in Neurofibromatosis Type 1 (tDCS is NF1)

Use of Non-invasive Brain Stimulation for Working Memory Deficits in Neurofibromatosis Type 1

Intellectual impairments are a significant cause of morbidity in children with birth defects along with long term implication on academic and occupational functioning. Long lasting functional changes in the brain occur when children learn new things or memorise new information. Enhancing this and learning is a key objective inneurodevelopment and neuro-rehabilitation. This is pilot study aimed at testing a experimental neuroscience technique, Transcranial Direct Current Stimulation (tCDS) on the cognitive functioning of the brain in children with Neurofibromatosis type 1 (NF1). tDCS is an established research tool and has the potential for ameliorating the cognitive impairments associated with NF1. There is a growing interest in the use of tDCS in children but to our knowledge there have been no reported studies using tDCS intervention in NF1. 16 children aged 11-16 years will be recruited through the Manchester Centre of Genomic Medicine NF1 database. Participants will be randomised to receive active or sham tDCS. The treatment will be delivered for 20 minutes for 3 days. In the experimental group a 1mA current will be applied for 20 mins ; in sham tDCS the electrodes will be placed in an identical spot but the current is ramped down to 30 seconds to prevent stimulation. The aim of the study is to look into the acceptability and feasibility of using tDCS intervention within the NF1 group, obtain pilot data on the effect of tDCS on EEG (Electroencephalogram), cognitive and behavioural measures.

Study Overview

• Status: Completed
• Conditions: Neurofibromatosis 1
• Intervention / Treatment: Other: Transcranial direct current stimulation

Detailed Description

16 children between the age of 11-16 years will be recruited through Manchester Centre of Genomic Medicine NF1 Database. The participants will be randomly assigned to 2 groups- active and sham treatment based on a computer generated random allocation list. The assessors will remain blind to treatment allocation.

On day 1, parents will be requested to complete well validated and standardised questionnaires. Baseline recording of the brain activity EEG(Electroencephalogram) will be measured and the baseline cognitive assessments will be completed on the participants. tCDS will be administered for 20 minutes alongside a simultaneous training task for working memory. Days 2, the tDCS (active or sham) will be delivered simultaneous with the training task for 20 minutes. On day 3, the tDCS intervention will be delivered followed by repeating the outcome measures similar to day 1.

A questionnaire investigating side-effects be will be completed by participant after each stimulation.Participants will be invited back to the lab 30 days (+/- 7 days) after the end of intervention to assess the longevity of any treatment effects.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9QQ
      • University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. children aged 11-16 years
2. With a confirmed diagnosis (wither clinical or genetic) of Neurofibromatosis Type 1
3. Informed consent/assent

Exclusion Criteria:

1. Child on active treatment for any NF1 related complications (such as chemotherapy for optic glioma)
2. Children with a known history of Epilepsy or on anti-epileptic medication
3. Children with poor verbal communication
4. Children with cardiac pacemakers, joint replacements or metal implants will be excluded.
5. Children with any previous operations to their head will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS Active arm; The experimental arm will have the tDCS stimulation electrodes placed on the scalp and the current will be delivered over 20 minutes	Other: Transcranial direct current stimulation; tDCS is an established research tool for non-invasive modulation of neuroplasticity. It has shown promise as a neurorehabilitation tool and demonstrated positive effects in various clinical conditions such as Alzheimer's, stroke, childhood psychosis, epilepsy and dystonias. tDCS uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential.; Other Names: Non-invasive brain stimulation
Placebo Comparator: tDCS Sham arm; The sham arm will have electrodes placed over the scalp and will be given the current for 10 seconds after which it will be ramped down and stopped.	Other: Transcranial direct current stimulation; tDCS is an established research tool for non-invasive modulation of neuroplasticity. It has shown promise as a neurorehabilitation tool and demonstrated positive effects in various clinical conditions such as Alzheimer's, stroke, childhood psychosis, epilepsy and dystonias. tDCS uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential.; Other Names: Non-invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
n-back test	visuo-spatial and auditory n-back test to assess working memory	Day 3 of intervention

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Shruti Garg, MRCPsych, PhD, University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: working memory
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: SGIRAS21773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We plan to make the data available to other researchers upon request once the study has been completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No