None listed
Conditions
Brief summary
This study aims to investigate whether a safe, non-invasive form of brain stimulation delivered at home can improve attention in children and young people aged 8–24 years following an acquired brain injury. Participants will be randomly assigned to receive one of two types of brain stimulation or a sham (placebo) stimulation while completing a computer-based attention training activity for 20 minutes a day over 10 weekdays. The first and last sessions will take place at the research centre, while the remaining sessions will be completed at home under video-call supervision from the research team. Participants will also complete assessments of attention, hand function, and brain activity before and after the intervention, as well as one week later to determine whether any effects are maintained. We hypothesise that active brain stimulation combined with attention training will lead to greater improvements in attention compared with sham stimulation. The findings from this study may help inform the development of safe and accessible therapies to support cognitive recovery following childhood-acquired brain injury.
Interventions
Children and young people aged 8–24 years with acquired brain injury will participate in a triple-blinded, randomised, sham-controlled trial evaluating home-based transcranial electrical stimulation (tES) delivered concurrently with attention training (NIBS-Attention).
Participants will be randomly allocated to one of three intervention arms:
• Arm 1: Active transcranial direct current stimulation (tDCS): 1 mA direct current delivered continuously for 20 minutes, including 60-second ramp-up an
Children and young people aged 8–24 years with acquired brain injury will participate in a triple-blinded, randomised, sham-controlled trial evaluating home-based transcranial electrical stimulation (tES) delivered concurrently with attention training (NIBS-Attention). Participants will be randomly allocated to one of three intervention arms: • Arm 1: Active transcranial direct current stimulation (tDCS): 1 mA direct current delivered continuously for 20 minutes, including 60-second ramp-up and 60-second ramp-down periods. • Arm 2: Active transcranial alternating current stimulation (tACS): 2 mA peak-to-peak sinusoidal stimulation (±1 mA amplitude), beta frequency stimulation (20 Hz), delivered continuously for 20 minutes, including 60-second ramp-up and 60-second ramp-down periods. • Arm 3: Sham tACS: stimulation will mimic the initial sensation of active stimulation using a 60-second ramp-up followed by a 30-second ramp-down period, after which no active current will be delivered for the remainder of the 20-minute session. Stimulation will be administered using a neuroConn DC-STIMULATOR PLUS device with two 5 × 5 cm saline-soaked sponge electrodes positioned bilaterally over the inferior frontal cortices according to the international 10–20 EEG system (F8 and F7). Stimulation will be delivered once daily from Monday to Friday over two consecutive weeks, for a total of 10 sessions. During stimulation, participants will complete a computerised attention training task consisting of a gamified stop-signal paradigm ("Sorting Game"). In this task, participants are required to sort visually presented stimuli according to predefined rules while inhibiting responses when stop signals are presented. The training is designed to engage attentional control and response inhibition processes. The task is delivered on a study laptop and lasts approximately 20 minutes, corresponding to the duration of stimulation. The first intervention session will take place in the clinic to assess tolerability, provide training on home administration procedures, and answer participant and caregiver questions. Baseline electroencephalography (EEG), behavioural measures, and neurocognitive assessments will be completed during this visit. Parents and/or carers will receive hands-on training and competency assessment in tES administration. Older adolescents may self-administer stimulation under supervision if deemed appropriate. Sessions 2–9 will be conducted at home under real-time remote supervision via videoconferencing (Zoom). Research personnel will monitor correct device setup, electrode placement, stimulation initiation, task completion, and participant wellbeing throughout each session. Adherence will be monitored using attendance logs, Zoom supervision records, stimulation device session logs, and completion checklists maintained by research staff. Missed or interrupted sessions will be documented. Participants will return to the clinic on Day 10 for the final stimulation session and repeat EEG and neurocognitive assessments. A follow-up visit will occur one week after completion of the intervention to assess maintenance of treatment effects. The Day 1 clinic visit will last approximately 3 hours, the Day 10 clinic visit approximately 1.5 hours, each home session approximately 45 minutes, and the one-week follow-up visit approximately 25 minutes. The primary outcome is response inhibition, measured using stop-signal reaction time obtained from the Stop-Signal Task. Secondary outcomes include interference inhibition measured using Flanker task congruency effects, fine motor dexterity measured using the Grooved Pegboard Test, and changes in functional brain connectivity assessed using EEG between baseline and Day 10.
Sponsors
Professor Karen Barlow, Centre for Children's Health Research, The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
• Acquired brain injury (including mild to severe traumatic brain injury [TBI]) • English language skills sufficient to comprehend study information and complete assessments (self-report) • At least three months post-injury for mild TBI. • At least 1 year after injury (for moderate to severe TBI) TBI severity • Mild: Obtained a Glasgow Coma Scale (GCS) score ranging from 13 to 15 during the emergency department assessment (if applicable); experienced post-traumatic amnesia (PTA) for less than 24 hours • Moderate: A loss of consciousness lasting from 30 minutes to 24 hours; a GCS score ranging from 9 to 12; a PTA period between 24 hours and 7 days • Severe: GCS is less than 9; PTA extends beyond 7 days
Exclusion criteria
• Contra-indications to tDCS o Metal implants o Current or suspected pregnancy or current lactation o Serious or unstable illness or medical condition o Skull defects underneath stimulation sites o Epilepsy or other seizure disorders o Scalp wound/skin problem preventing placement of EEG and stimulation leads • Acquired brain injury due to hypoxic-ischemic encephalopathy • Profound memory impairments according to medical history • Significant past medical or psychiatric history before injury • Recent or planned change in neuroactive drugs (i.e., changed within 3 weeks of tES; e.g., anticonvulsants, benzodiazepines, GABA antagonists, etc.). The short-acting ADHD medication will be paused for 48 hours before the study begins. • Existing neurological conditions, such as moderate to severe learning disabilities • The existence of a condition or abnormality that, in the Investigator's judgment, could jeopardize the patient's safety or the integrity of the data.
Outcome results
None listed