Clinical trial · Interventional
Non-invasive Stimulation in Neurofibromatosis Type 1
Use of Non-invasive Brain Stimulation for Working Memory Deficits in Neurofibromatosis Type 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcranial direct current stimulation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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
- interventionNames
- Other: Transcranial direct current stimulation
- type
- PLACEBO_COMPARATOR
- label
- tDCS Sham arm
- description
- 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.
- interventionNames
- Other: Transcranial direct current stimulation
Primary outcomes (1)
- measure
- n-back test
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBooth 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