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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Consciousness Disorder
- Sponsor
- University of Birmingham
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Retention at 6 months
- Last Updated
- 5 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Retention at 6 months
Time Frame: 6 months after start of participation
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
Completion
Time Frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
percentage of tDCS, MRI, and electrophysiology assessments completed per polarity
Retention at end of active phase
Time Frame: through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream
percentage of participants on study at pre-specified time points counted from the start of participation in the study (i.e., first study procedure)
Retention at 3 months
Time Frame: 3 months after start of participation
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
Secondary Outcomes
- Functional MRI in response to task instructions(day 1 and day 5 of tDCS each polarity)
- EEG power in the beta band in response to task instructions(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(days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively)
- Structural MRI(day 1 and day 5 of tDCS each polarity)
- EEG power in the alpha band in response to task instructions(days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream)
- Coma recovery scale -revised(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(at 3 and 6 months after start of participation)