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