None listed
Conditions
Brief summary
Traumatic Brain Injury (TBI) can lead to fundamental changes in a person’s ability to function day-to-day. The development of cognitive impairment is a particularly common and disabling consequence. As such, rehabilitation of cognition is an important part of post head injury treatment but current standard cognitive rehabilitation (consisting of either re-training / remediating impaired abilities) has generally resulted in only modest improvements in functioning. Our study will explore an innovative approach to repairing cognitive functioning following TBI that combines biological modulation of neural systems with behavioural remediation. We will combine transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training and examine the effectiveness of this combination using a Randomised Controlled Trial design. The ultimate aim of this research is the development of an effective targeted treatment for cognitive impairment following TBI to allow for a more complete recovery following injury.
Interventions
Participants will undergo repeated sessions (20 in total) of Transcranial Direct Current Stimulation (tDCS). tDCS involves the application of a very gentle electrical current applied using two surface electrodes (anode and cathode) to the scalp . tDCS has been shown to increase brain activity in areas important for cognition.
Participants will be randomly allocated to one of the following two conditions;
1. Twenty sessions of 20 minute active tDCS to the left Dorsolateral Prefrontal Cortex (DLP
Participants will undergo repeated sessions (20 in total) of Transcranial Direct Current Stimulation (tDCS). tDCS involves the application of a very gentle electrical current applied using two surface electrodes (anode and cathode) to the scalp . tDCS has been shown to increase brain activity in areas important for cognition. Participants will be randomly allocated to one of the following two conditions; 1. Twenty sessions of 20 minute active tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC) at a current density of 0.0057 ma/cm over four weeks, Monday-Friday combined with computerised cognitive training using 'Brain HQ' a commercially available cognitive training package from Posit Science. 2. Twenty sessions of 20 minute sham tDCS to the left DLPFC at a current density of 0.0057 ma/cm over four weeks, Monday-Friday combined with computerised cognitive training using 'Brain HQ' a commercially available cognitive training package from Posit Science. The computerised cognitive training will be completed on a laptop computer for 5 x 30 minute sessions per week for 4 weeks. Cognitive training will be completed in the presence of a research assistant who will monitor engagement/adherence with the training. The computerised tasks are designed to target attention, processing speed and memory.
Sponsors
Dr Kate Hoy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be included if they: (1) are aged 18-65 and have capacity to consent; (2) have experienced a closed head injury of mild to moderate severity determined by patient reports and hospital records of a loss of consciousness (LOC) of less than 24 hours, and an initial GCS of more than 9 ; (3) are at least 6 weeks post injury to allow a degree a recovery from injuries sustained from the TBI prior to entering the trial; (4) have an IQ of greater than 70 as determined by performance on the Wechsler Test of Adult Reading (WTAR) (to ensure they understand the study requirements) ; (5) exhibit cognitive impairment, defined as a performance greater than 1 SD below published norms on any domain within the MATRICS.
Exclusion criteria
Participants will be excluded if they (1) have a diagnosis of a Psychiatric illness, lifetime (i.e. either pre or post TBI). In particular, as rTMS is known to effectively treat depression and this may impact upon the outcome variables, the presence of a depressive disorder (DSM 5 criteria) will exclude participation; (2) have drug dependence or abuse; (3) have a personal or family history of a seizure disorder; (4) an unstable medical condition, neurological disorder, are currently pregnant or lactating; (5) have metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
Outcome results
None listed