Non-invasive Stimulation in Neurofibromatosis Type 1

NCT ID: NCT03310996

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Neurofibromatosis 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

NeuroConn DC-STIMULATOR PLUS (NeurConn, GmbH), model number: 0021; serial number: 0351
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Transcranial direct current stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Non-invasive brain stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Dr Shruti Garg

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shruti Garg, MRCPsych, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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University of Manchester

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37608248 (View on PubMed)

Other Identifiers

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SGIRAS21773

Identifier Type: -

Identifier Source: org_study_id

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