Combining Transcranial Direct Current Stimulation (tDCS) with Cognitive Training for Cognitive Impairment following Traumatic Brain Injury: A Pilot Study
- Conditions
- Traumatic Brain Injury (TBI)Injuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12615000578505
- Lead Sponsor
- Dr Kate Hoy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MATRICS Consensus battery<br>The MATRICS battery is a multi-domain cognitive battery specifically designed for repeated use. We will be<br>assessing the domains of speed of processing, attention, verbal learning, working memory, visual learning, reasoning, and problem solving.<br>Although all of these domains are measured separately by the MATRICS, it also allows for a Global Cognition score to be calculated.<br>This is a composite primary outcome.<br>[Baseline and Endpoint (i.e. pre and post 20 sessions of tDCS stimulation)]
- Secondary Outcome Measures
Name Time Method TMS-EEG data.<br>TMS-EEG is performed by stimulating the scalp over the DLPFC while<br>simultaneously recording brain activity via surrounding EEG electrodes.<br>The TMS pulse produces a neurophysiological response in the underlying cortex, referred to as a TMS evoked potential (TEP), which is recorded onEEG and the TEP amplitude gives an index of cortical excitability.[Baseline and Endpoint (i.e. pre and post 20 sessions of tDCS)]