Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001562763
Ethics application status
Approved
Date submitted
16/11/2022
Date registered
19/12/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility of home-based, remotely-supervised transcranial direct current stimulation (tDCS) during attention training in children with acquired brain injury
Scientific title
Investigating the feasibility and tolerability of home-based, remotely-supervised transcranial direct current stimulation (tDCS) during attention training in children with acquired brain injury
Secondary ID [1] 308409 0
None
Universal Trial Number (UTN)
Trial acronym
hrtDCS-Attention
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury in children 328212 0
Condition category
Condition code
Neurological 325262 325262 0 0
Other neurological disorders
Injuries and Accidents 325321 325321 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be children with acquired brain injury, aged 8-18 years.

In these participants, transcranial direct current stimulation (tDCS) will be administered during attention training for 10 consecutive weekdays from home during remote supervision ('hrtDCS-Attention'). tDCS will be administered once daily (20 minutes, during attention training), over left and right frontal areas of the brain (e.g. dorsolateral prefrontal cortex, dlPFC) with 5x5 cm sponge electrodes. Anode will be placed over F3, cathode over F4.

This is an open label trial with two active study arms:
Arm 1: 1 mA tDCS
Arm 2 (dose comparator): 2 mA tDCS

The first hrtDCS-Attention session will take place in the clinic to ensure initial tolerability, provide information about the home sessions and training to conduct them, and answer any questions. Electroencephalography (EEG) and baseline neurocognitive outcomes will be recorded. MRI will be undertaken if consent is obtained (MRI is optional to participants). After the first session, hrtDCS-Attention sessions will be conducted at home using remote supervision (i.e. through video call) to ensure correct use of the device, adherence to the protocol, safety and support. Parents and/or carers who were trained in-clinic will administer tDCS to children. For older adolescents, tDCS might be self-administered over video call. As well as prior training by tDCS personnel, participants will be given a specifically designed home-based tDCS information guide tailored for hrtDCS-Attention. hrtDCS-Attention will occur from Monday to Friday for two consecutive weeks for a total of 10 sessions. Participants will return to the clinic on tDCS Day 10, where the final (10th) session will take place in clinic, together with an EEG and neurocognitive outcomes. Follow up assessment at 1- and 4-weeks post-tDCS will be conducted remotely.

In-clinic Session on Day 1 will take approximately 4 hours, In-clinic Session on Day 10 will take approximately 1.5 hours. Daily home-based sessions will take approximately 45 minutes. Follow up sessions will take approximately 25 minutes.

The primary outcome is feasibility and tolerability, measured by sensations recorded during tDCS sessions, compliance to tDCS sessions, and the participant/family's views or comments about the sessions. We will also assess preliminary efficacy, according to changes in reaction time across the 10 days of tDCS and change in functional brain connectivity between baseline and day 10 of tDCS.
Intervention code [1] 324863 0
Treatment: Devices
Intervention code [2] 324864 0
Rehabilitation
Comparator / control treatment
Open label - two active arms, no healthy control participants.
Arm 1: tDCS 1 mA
Arm 2 (dose comparator): tDCS 2 mA
Control group
Dose comparison

Outcomes
Primary outcome [1] 333108 0
Feasibility of hrtDCS-Attention assessed by adherence to study protocol via remote supervision
Timepoint [1] 333108 0
Following Day 10 of tDCS.
Primary outcome [2] 333182 0
Additional primary outcome: Tolerability of hrtDCS-Attention assessed by tDCS sensations questionnaire (including adverse events) and family/participant comment about overall tolerability (qualitative).
Timepoint [2] 333182 0
Following Day 10 of tDCS
Secondary outcome [1] 415852 0
Flanker task choice reaction time
Timepoint [1] 415852 0
At baseline; At the beginning of each daily hrtDCS-session (pre-tDCS); 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [2] 415853 0
Stop Signal reaction time
Timepoint [2] 415853 0
At baseline; During each daily hrtDCS-session; 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [3] 415854 0
Go/No-Go reaction time
Timepoint [3] 415854 0
At baseline; during hrtDCS session 10 (post-tDCS); 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [4] 415855 0
Attention assessed using Conner's short form - parent and child versions
Timepoint [4] 415855 0
At Baseline; During tDCS session 10 (post-tDCS); 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [5] 415856 0
Functional connectivity (HD-EEG)
Timepoint [5] 415856 0
Baseline, tDCS day 10
Secondary outcome [6] 415857 0
Association between functional MRI at baseline and attention measured using the Flanker task
Timepoint [6] 415857 0
Baseline fMRI (optional for participants) and flanker task assessed at hrtDCS Day 10, 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [7] 416084 0
Flanker task accuracy
Timepoint [7] 416084 0
At baseline; At the beginning of each daily hrtDCS-session (pre-tDCS); 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [8] 416086 0
Stop Signal accuracy
Timepoint [8] 416086 0
At baseline; During each daily hrtDCS-session; 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention
Secondary outcome [9] 416088 0
Go/No-Go accuracy
Timepoint [9] 416088 0
At baseline; during hrtDCS session 5 (post-tDCS); during hrtDCS session 10 (post-tDCS); 1 week follow up after completion of 10 days of hrtDCS-Attention; 4 week follow up after completion of 10 days of hrtDCS-Attention

Eligibility
Key inclusion criteria
• Aged between 7 and 18 years (inclusive)
• Acquired brain injury (including mild to severe TBI)
• English language skills sufficient to comprehend study information and complete assessments (self-report)
• At least 3 months post injury (for mild TBI)
• At least one year post-injury (for moderate – severe TBI)
• Access to internet at home


TBI injury severity
• Mild: Received a Glasgow coma scale (GCS) score of between 13 and 15 upon ED evaluation (if available); experienced <24 h post-traumatic amnesia (PTA)
• Moderate: Loss of consciousness between 30 min and 24 h; GCS between 9 and 12; PTA between 24 h and 7 days]
• Severe: GCS<9; PTA for more than 7 days]
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contra-indications to tDCS e.g.
- Metal implants
- Serious or unstable illness or medical condition
- Current or suspected pregnancy or current lactation
- Skull defects underneath stimulation sites
- Scalp wound/skin problem preventing placement of EEG and stimulation leads
- Epilepsy or other seizure disorders

• Acquired brain injury due to hypoxic-ischemic encephalopathy

• Significant past medical or psychiatric history before injury

• Profound memory impairments according to medical history

• Recent or planned change in neuroactive drugs (i.e., changed within 3 weeks of tDCS; e.g., anticonvulsants, benzodiazepines, GABA antagonists, etc.).

• Pre-existing neurological disorder, including moderate to severe learning difficulties

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed to staff determining if a subject is eligible for inclusion
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software. This list will be kept in a locked cupboard on site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
20 participants should be sufficient to assess feasibility and tolerability. For attention outcomes, sample size was calculated based on mean alpha band EEG power of Ulam, Shelton 11. According to results from the repeated measures ANOVA (within participants design, pre to post tDCS mean EEG alpha power), n=30 participants (n=15 in each group) should allow for a moderate effect size in our study. Participants will be included in analysis if they have completed at least 80% of sessions (8 sessions).

Statistical questions

Primary RQ
1. Is it feasible to conduct 10 consecutive weekday sessions of hrtDCS-Attention in children aged 8-18 years with ABI, as measured by:
a. Compliance
b. Sensations/adverse events?

Compliance (i.e. number of missed sessions; number of sessions prematurely terminated), and tolerability (type and characteristics of any adverse effects) will be described and tabulated by group. Qualititative outcomes include participants’ (1) experience with and (2) thoughts and feelings about the home-based tDCS.

Secondary RQs

1. Can 10 consecutive weekday sessions of hrtDCS-Attention improve attentional inhibition across the tDCS intervention?
Repeated measures ANOVA will be used, assuming normally distributed data. Reaction time and accuracy of the Flanker, Go/No-Go and Stop Signal tasks will be compared across the 10 days of tDCS.


2. Does the effect of hrtDCS-Attention persist at 1 week and 4 weeks?
Repeated measures ANOVA will be used, assuming normally distributed data. Reaction time and accuracy of the Flanker, Go/No-Go and Stop Signal tasks will be compared across tDCS day 10, and 1 and 4 week follow up.

3. Can hrtDCS-Attention cause significant changes in functional connectivity?
EEG data will be preprocessed, and connectivity analyses will be conducted. Brain connectivity measures will be statistically compared at baseline and on Day 10 of tDCS.

4. Does functional connectivity at baseline predict response to hrtDCS-Attention?
MRI and EEG data will be preprocessed, and connectivity analyses will be conducted. Connectivity measures at baseline will be regressed against neurocognitive task data across and/or following the 10 days of tDCS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2023
Actual
30/01/2023
Date of last participant enrolment
Anticipated
3/07/2024
Actual
Date of last data collection
Anticipated
3/09/2024
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23563 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 38985 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312657 0
University
Name [1] 312657 0
Professor Karen Barlow - Start Up Funds from The University of Queensland
Country [1] 312657 0
Australia
Primary sponsor type
Individual
Name
Professor Karen Barlow
Address
The University of Queensland Centre for Children's Health Research, 62 Graham St South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 314269 0
None
Name [1] 314269 0
Address [1] 314269 0
Country [1] 314269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311964 0
CHILDREN’S HEALTH QUEENSLAND HOSPITAL AND HEALTH SERVICE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 311964 0
Ethics committee country [1] 311964 0
Australia
Date submitted for ethics approval [1] 311964 0
21/10/2022
Approval date [1] 311964 0
26/10/2022
Ethics approval number [1] 311964 0
HREC/21/QCHQ/73034 protocol f6.0 amendment
Ethics committee name [2] 311965 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 311965 0
Ethics committee country [2] 311965 0
Australia
Date submitted for ethics approval [2] 311965 0
09/11/2022
Approval date [2] 311965 0
09/11/2022
Ethics approval number [2] 311965 0
2021/HE001116

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122990 0
Prof Karen Barlow
Address 122990 0
Centre for Children's Health Research, Level 6
62 Graham St South Brisbane QLD 4101
Country 122990 0
Australia
Phone 122990 0
+61 7 3069 7486
Fax 122990 0
Email 122990 0
[email protected]
Contact person for public queries
Name 122991 0
Athena Stein
Address 122991 0
Centre for Children's Health Research, Level 6
62 Graham St South Brisbane QLD 4101
Country 122991 0
Australia
Phone 122991 0
+61 7 3069 7555
Fax 122991 0
Email 122991 0
[email protected]
Contact person for scientific queries
Name 122992 0
Athena Stein
Address 122992 0
Centre for Children's Health Research, Level 6
62 Graham St South Brisbane QLD 4101
Country 122992 0
Australia
Phone 122992 0
+61 7 3069 7555
Fax 122992 0
Email 122992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant outcome data including safety and tolerability, reaction times on attention tasks
When will data be available (start and end dates)?
By 5 years after final recruitment - expected by 03/08/2029 until 3/8/2030
Available to whom?
Upon reasonable request
Available for what types of analyses?
Chosen by researcher
How or where can data be obtained?
emailing PI or public contact of this trial
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17625Study protocol  [email protected]
17626Statistical analysis plan  [email protected]
17627Informed consent form  [email protected]
17628Ethical approval  [email protected]



Results publications and other study-related documents

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