Non-invasive Stimulation in Neurofibromatosis Type 1

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Brief Title

Non-invasive Stimulation in Neurofibromatosis Type 1

Official Title

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

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


Primary Outcome

n-back test


Condition

Neurofibromatosis 1

Intervention

Transcranial direct current stimulation

Study Arms / Comparison Groups

 tDCS Active arm
Description:  The experimental arm will have the tDCS stimulation electrodes placed on the scalp and the current will be delivered over 20 minutes

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

16

Start Date

October 13, 2017

Completion Date

June 30, 2018

Primary Completion Date

June 30, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

11 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Shruti Garg, MRCPsych, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03310996

Organization ID

SGIRAS21773


Responsible Party

Principal Investigator

Study Sponsor

University of Manchester


Study Sponsor

Shruti Garg, MRCPsych, PhD, Principal Investigator, University of Manchester


Verification Date

April 2019