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

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ClinicalTrials.gov Identifier: NCT03310996
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Shruti Garg, University of Manchester

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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis 1 Other: Transcranial direct current stimulation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: NeuroConn DC-STIMULATOR PLUS (NeurConn, GmbH), model number: 0021; serial number: 0351
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Use of Non-invasive Brain Stimulation for Working Memory Deficits in Neurofibromatosis Type 1
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018


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 Name: 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 Name: Non-invasive brain stimulation




Primary Outcome Measures :
  1. n-back test [ Time Frame: Day 3 of intervention ]
    visuo-spatial and auditory n-back test to assess working memory



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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310996


Contacts
Contact: Shruti Garg, PhD +441613067967 shruti.garg@manchester.ac.uk

Locations
United Kingdom
University of Manchester Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9QQ
Contact: Admin    +44 1613067961      
Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Shruti Garg, MRCPsych, PhD University of Manchester

Responsible Party: Dr Shruti Garg, Dr, University of Manchester
ClinicalTrials.gov Identifier: NCT03310996     History of Changes
Other Study ID Numbers: SGIRAS21773
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to make the data available to other researchers upon request once the study has been completed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Shruti Garg, University of Manchester:
working memory

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
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
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms