Clinical trial NCT04248946: Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Consciousness Disorder
Brain Injuries
Vegetative State
Minimally Conscious State
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Wellington Hospital
First posted: 2020-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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 sites
Primary purpose: BASIC_SCIENCE

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Receiving care at a recruitment site, with a consensus clinical diagnosis of PDOC from any aetiology (i.e. traumatic or non-traumatic injury).
* Stable and with no need of mechanical support (i.e. respirator, etc.)

Exclusion Criteria:

* Scalp skin sores or any skin damage at the electrode sites
* Metallic implants in the face or skull
* Craniectomy or cranioplasty
* No evidence of auditory startle in clinical observations, or absent brainstem auditory evoked potentials in recent clinical history (if data available)
* MRI incompatible: metal plates incompatible with MRI scanners, pacemaker, inability to lay flat for prolonged periods of time, aneurysm clips, neurostimulators, brain/subdural electrodes, etc. (MRI stream ONLY)

Primary outcomes:
measure: Retention at end of active phase
timeFrame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
measure: Retention at 3 months
timeFrame: 3 months after start of participation
measure: Retention at 6 months
timeFrame: 6 months after start of participation
measure: Completion
timeFrame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
Secondary outcomes:
measure: Structural MRI
timeFrame: day 1 and day 5 of tDCS each polarity
measure: Functional MRI in response to task instructions
timeFrame: day 1 and day 5 of tDCS each polarity
measure: EEG power in the alpha band in response to task instructions
timeFrame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
measure: EEG power in the beta band in response to task instructions
timeFrame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
measure: EMG (electromyography) amplitude changes
timeFrame: days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively
measure: Coma recovery scale -revised
timeFrame: regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream
measure: Glasgow Outcome Scale-extended
timeFrame: at 3 and 6 months after start of participation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Moseley Hall Hospital
state: West Midlands
city: London
country: United Kingdom
facility: The Wellington Hospital
Study officials:
References: