Brain Injuries Clinical Trial
— RAINDROPOfficial 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
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
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Moseley Hall Hospital | Birmingham | West Midlands |
United Kingdom | The Wellington Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | Wellington Hospital |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream | |
Primary | 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 | 3 months after start of participation | |
Primary | 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 | 6 months after start of participation | |
Primary | Completion | percentage of tDCS, MRI, and electrophysiology assessments completed per polarity | through completion of active phase of study (tDCS intervention), on average 4 weeks for bedside stream and 8 weeks for MRI stream | |
Secondary | Structural MRI | This will include assessments of the gross macrostructure, and microstructure of brain tissue grey matter, white matter, and cerebrospinal fluid | day 1 and day 5 of tDCS each polarity | |
Secondary | 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 | day 1 and day 5 of tDCS each polarity | |
Secondary | EEG power in the alpha band in response to task instructions | Envelope of bandpass filtered EEG data between 8-12 Hertz | days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream | |
Secondary | EEG power in the beta band in response to task instructions | Envelope of bandpass filtered EEG data between 13-30 Hertz | days 1 and 4 of each polarity in the MRI stream and day 1 of each polarity in the bedside stream | |
Secondary | EMG (electromyography) amplitude changes | Changes in the amplitude of the rectified EMG signal (high-pass filtered > 50Hz) in response to instructions to move | days 1-4 and day 2 of each polarity in the MRI and bedside streams respectively | |
Secondary | 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 | regularly through active phase of study (baseline and outcome assessments), on average 4 weeks for bedside stream and 8 weeks for MRI stream | |
Secondary | 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 | at 3 and 6 months after start of participation |
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