Investigating the feasibility of home-based, remotely-supervised transcranial direct current stimulation (tDCS) during attention training in children with acquired brain injury

Not Applicable

Recruiting

• Conditions: acquired brain injury in children; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12622001562763
• Lead Sponsor: Professor Karen Barlow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-19
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified