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Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study — RAINDROP  

Brain Injuries Clinical Trial

Official title:
Sham-controlled, Double-blind, Randomised Crossover Study of the Neural, Behavioural, and Clinical Effects of Transcranial Direct Current Stimulation in Patients With a Prolonged Disorder of Consciousness; Feasibility Study

Clinical Trial Summary

This study evaluates the feasibility of an experimental protocol that combines advanced multi-modal imaging of the brain with clinical and behavioural scales to characterise the neural, behavioural, and clinical effects of transcranial direct current stimulation (tDCS) for rehabilitation in PDOC

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04248946
Study type Interventional
Source University of Birmingham
Contact Davinia Fernandez Espejo, PhD FHEA
Phone 01214145534
Email d.fernandez-espejo@bham.ac.uk
Status Not yet recruiting
Phase N/A
Start date July 2021
Completion date August 2022
View Details
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