Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Injuries
- Consciousness Disorder
- Minimally Conscious State
- Vegetative State
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a double-blind randomised crossover feasibility study of tDCS in a small cohort of PDOC individuals. The study is divided into two streams to accommodate differences in the resources available across recruitment sites: 1. MRI stream, which will include MRI and electrophysiology assessments; this is available to patients receiving care at the Wellington Hospital in London only. 2. Bedside stream, which will include electrophysiology assessments only, available to patients in specialist units at NHS (National Health Service) and non-NHS sitesMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: In the MRI stream all participants will receive anodal, cathodal, and sham (placebo) tDCS sessions in a randomised order. In the Bedside stream participants will receive active tDCS (either anodal or cathodal) and sham sessions also in a randomised order. A researcher not involved in data collection or analyses will programme the stimulator to deliver the specific polarity needed in each session in a double-blind manner. Sham tDCS will be delivered according to published guidelines: this mimics the physical sensations of active stimulation but does not have a neuromodulatory effectPrimary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients with prolonged disorders of consciousness (PDOC) have very limited therapeutic options, and they often show little to no progress over time. Here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. The investigators will use a...
Patients with prolonged disorders of consciousness (PDOC) have very limited therapeutic options, and they often show little to no progress over time. Here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. The investigators will use a protocol designed to target specific brain networks that have been shown to play a key role in explaining the lack of voluntary responses in PDOC. The study will focus on characterising the mechanisms of action of tDCS and the bases for potential individual differences in responsiveness to the stimulation across participants. This feasibility study is the first step towards developing personalised tDCS interventions to restore external responsiveness in PDOC patients. Its results will inform the design of a future trial fully powered for characterising neural, behavioural, and clinical effects of tDCS in PDOC as well as the mechanisms underlying individual differences in responsiveness.
Tracking Information
- NCT #
- NCT04248946
- Collaborators
- Wellington Hospital
- Investigators
- Not Provided
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