Neurofibromatosis 1tDCS is NF1NCT03310996
Non-invasive Stimulation in Neurofibromatosis Type 1
A study testing Transcranial direct current stimulation in people with Neurofibromatosis 1, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Neurofibromatosis 1
- What is being tested?
- Transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 11-16 years
- With a confirmed diagnosis (wither clinical or genetic) of Neurofibromatosis Type 1
- Informed consent/assent
Who cannot join
- Child on active treatment for any NF1 related complications (such as chemotherapy for optic glioma)
- Children with a known history of Epilepsy or on anti-epileptic medication
- Children with poor verbal communication
- Children with cardiac pacemakers, joint replacements or metal implants will be excluded.
- Children with any previous operations to their head will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9QQ
About this study
Official title: Use of Non-invasive Brain Stimulation for Working Memory Deficits in Neurofibromatosis Type 1
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.
Read the 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.
- Conditions
- Neurofibromatosis 1
- Being tested
- Transcranial direct current stimulation
- Keywords
- working memory
- Medical subject headings
- Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationOther
Also called Non-invasive brain 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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Active arm | Experimental | The experimental arm will have the tDCS stimulation electrodes placed on the scalp and the current will be delivered over 20 minutes Receives: Other: Transcranial direct current stimulation |
| tDCS Sham arm | Placebo comparator | 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. Receives: Other: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
n-back test
visuo-spatial and auditory n-back test to assess working memory
Measured: Day 3 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start13 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- NeuroConn DC-STIMULATOR PLUS (NeurConn, GmbH), model number: 0021; serial number: 0351
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shruti Garg, University of Manchester
- Investigators
- Shruti Garg, MRCPsych, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310996
- Sponsor's protocol ID
- SGIRAS21773
- Acronym
- tDCS is NF1
- Status last verified
- Apr 2019
- First submitted
- 10 Oct 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to make the data available to other researchers upon request once the study has been completed.
Publications
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.
PubMed 37608248
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Non-invasive Brain Stimulation for Working Memory Deficits in Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT03310996
- Acronym / sponsor ID
- tDCS is NF1 / SGIRAS21773
- Conditions
- Neurofibromatosis 1
- Keywords
- working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- NeuroConn DC-STIMULATOR PLUS (NeurConn, GmbH), model number: 0021; serial number: 0351
| Arm | Type | Receives |
|---|---|---|
| tDCS Active arm | Experimental | Other: Transcranial direct current stimulationThe experimental arm will have the tDCS stimulation electrodes placed on the scalp and the current will be delivered over 20 minutes |
| tDCS Sham arm | Placebo comparator | Other: Transcranial direct current stimulationThe 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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 11-16 years
- With a confirmed diagnosis (wither clinical or genetic) of Neurofibromatosis Type 1
- Informed consent/assent
Key exclusion criteria (5 listed)
- Child on active treatment for any NF1 related complications (such as chemotherapy for optic glioma)
- Children with a known history of Epilepsy or on anti-epileptic medication
- Children with poor verbal communication
- Children with cardiac pacemakers, joint replacements or metal implants will be excluded.
- Children with any previous operations to their head will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAlso: Non-invasive brain stimulationtDCS 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 | tDCS Active arm, tDCS Sham arm |
Primary outcome
n-back test
Time frame: Day 3 of intervention
visuo-spatial and auditory n-back test to assess working memory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 37608248Booth 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.
- Individual participant dataSharing planned: Undecided. We plan to make the data available to other researchers upon request once the study has been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shruti Garg, MRCPsych, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Neurofibromatosis 1, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
n-back test (time frame: Day 3 of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.