Non-invasive Stimulation in Neurofibromatosis Type 1

NCT03310996 | Completed

• 1 other identifier: SGIRAS21773
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurofibromatosis 1

Keywords

working memory

Outcome Measures

Primary Outcomes (1)

• n-back test

  visuo-spatial and auditory n-back test to assess working memory

  Day 3 of intervention

Study Arms (2)

tDCS Active arm

EXPERIMENTAL

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 Sham arm

PLACEBO COMPARATOR

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

Interventions

Transcranial direct current stimulation OTHER

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.

Also known as: Non-invasive brain stimulation

tDCS Active arm; tDCS Sham arm

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9QQ, United Kingdom

Location

Related Publications (1)

• Booth SJ, Garg S, Brown LJE, Green J, Pobric G, Taylor JR. Aberrant oscillatory activity in neurofibromatosis type 1: an EEG study of resting state and working memory. J Neurodev Disord. 2023 Aug 22;15(1):27. doi: 10.1186/s11689-023-09492-y.

  PMID: 37608248 DERIVED

MeSH Terms

Conditions

Neurofibromatosis 1

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shruti Garg, MRCPsych, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both sham and active treatment arms will have electrodes places on the scalp. The sham arm will have the current turned off in 10 seconds.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: NeuroConn DC-STIMULATOR PLUS (NeurConn, GmbH), model number: 0021; serial number: 0351

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: October 13, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

GB (1)