An interventional study of Transcranial direct current stimulation in Consciousness Disorder, Brain Injuries and Vegetative State, sponsored by University of Birmingham. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by University of Birmingham · Not applicable, Interventional, and Basic science
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
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 15 is below the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
In this stream all patients receive 2 experimental interventions (anodal tDCS and cathodal tDCS) and a sham intervention (sham tDCS). These are delivered in randomised order, ensuring a balanced distribution of participants across possible orders. They will receive 5 sessions per condition (on consecutive days), for a total of 15 sessions. I. Anodal, cathodal, sham II. Anodal, sham, cathodal III. Cathodal, anodal, sham IV. Cathodal, sham, anodal V. Sham, anodal, cathodal VI. Sham, cathodal, anodal
Other: Transcranial direct current stimulation
In this stream all patients receive 1 experimental interventions (either anodal tDCS or cathodal tDCS) and 1 sham intervention (sham tDCS). These include only 1 session per condition and are delivered in randomised order, resulting in the following possible combinations: I. Anodal, sham II. Cathodal, sham III. Sham, anodal IV. Sham, cathodal Participants will be randomly assigned to the above groups ensuring a balanced distribution of participants across them.
Other: Transcranial direct current stimulation
tDCS alters neural excitability in a polarity-specific manner via a weak direct electric current delivered through electrodes placed on the scalp. There are 3 types of stimulation: anodal, cathodal, and sham. In anodal tDCS, the positive electrode is placed over the target brain area to increase neuronal excitability. In cathodal tDCS, the negative electrode is placed over the target brain area to decrease neuronal excitability. Sham tDCS emulates the physical sensations of active (anodal/cathodal) tDCS but current is only delivered for a short period of time and is not enough to cause any neuromodulations
Also known as: tDCS
Retention at end of active phase
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure)
Time frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
Retention at 3 months
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only
Time frame: 3 months after start of participation
Retention at 6 months
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure). This Outcome applies to the bedside stream only
Time frame: 6 months after start of participation
Completion
percentage of tDCS, MRI, and electrophysiology assessments completed per polarity
Time frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
Structural MRI
This will include assessments of the gross macrostructure, and microstructure of brain tissue grey matter, white matter, and cerebrospinal fluid
Time frame: day 1 and day 5 of tDCS each polarity
Functional MRI in response to task instructions
This will include assessments of the BOLD (blood oxygen level-dependent) response to characterise brain activity and connectivity during command following
Time frame: day 1 and day 5 of tDCS each polarity
EEG power in the alpha band in response to task instructions
Envelope of bandpass filtered EEG data between 8-12 Hertz
Time frame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
EEG power in the beta band in response to task instructions
Envelope of bandpass filtered EEG data between 13-30 Hertz
Time frame: days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream
EMG (electromyography) amplitude changes
Changes in the amplitude of the rectified EMG signal (high-pass filtered \> 50Hz) in response to instructions to move
Time frame: days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively
Coma recovery scale -revised
clinical diagnostic scale for disorders of consciousness. Total score ranges from 0 to 23, where higher scores mean a higher level of functioning and awareness
Time frame: regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream
Glasgow Outcome Scale-extended
Scale for functional outcome after brain injury. Total score ranges from 1 to 8, where higher values correspond to better outcome
Time frame: at 3 and 6 months after start of participation
Plan to share: No
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