None listed
Conditions
Brief summary
This study is an open-label, Phase I safety and feasibility trial, named 'hrtDCS-Attention'. We aim to evaluate whether 10 weekdays of home-based, remotely supervised transcranial direct current stimulation (tDCS) for 20 minutes during attention training is feasible and tolerable in children aged 8-18 years with acquired brain injury. tDCS will be applied once daily on the scalp, over the left and right prefrontal cortex. Participants will be randomised to one of two trial arms, to receive either (1) 1 mA of tDCS or (2) 2 mA of tDCS. Participants will be blinded to which dose they have been assigned to. 15 participants will be assigned to each group, for a total of 30 participants in hrtDCS-Attention. 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 from participants. HD-EEG and other baseline neurocognitive outcomes will be recorded. After the first session, participants will conduct hrtDCS-Attention sessions at home using remote supervision (i.e. through video call) to ensure correct use of the device, adherence to the protocol, safety and support. As well as receiving prior training by tDCS personnel, participants will be given an information guide to use tDCS from home. 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. 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.
Interventions
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
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.
Sponsors
Professor Karen Barlow
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
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]
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.
Outcome results
None listed