Consciousness Disorder
Conditions
Keywords
disorders of consciousness, electric stimulation
Brief summary
Altered gamma activity has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.
Detailed description
We propose a matched-pair parallel study in patients with disorders of consciousness to investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain oscillations, as measured by electroencephalography (EEG), and whether the brain activity changes are coupled with improvements in consciousness.
Interventions
DEVICEDC-Stimulator, NeuroConn, Germany
Neurostimulation device
Sponsors
Maastricht University
Zhejiang Mingzhou Brain Rehabilitation Hospital
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of disorders of consciousness based on CRS-R * Time post-injury ranging from one to twelve months * No history of acquired brain injury or psychiatric or neurological diseases
Exclusion criteria
* Not medically stable * Any contraindication to electric stimulation * Hearing impairment before brain injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale-Revised scores | Day 1-5, Day 11-15 | Coma Recovery Scale-Revised(CRS-R) scores are the gold standard for consciousness. CRS-R consists of 23 items, grouped into 6 sub-scales: auditory, visual, motor, oromotor, communication and arousal. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best). |
| Neuropsychological assessment | Day 5 and Day 11 | EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300). |
| Glasgow Outcome Scale-Extended | 1 year after stimulation | A widely used index for outcomes after brain injury |
Countries
China
Outcome results
None listed