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| Name | Class |
|---|---|
| Maastricht University | OTHER |
| Zhejiang Mingzhou Brain Rehabilitation Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma modulation effect | Experimental | 40Hz current is applied by a battery-driven current stimulator(NeuroConn, Germany). Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3), respectively. 40Hz acoustic stimuli and 40Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days. |
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| Beta modulation effect | Experimental | 28Hz current is applied by a battery-driven current stimulator. Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3). 28Hz acoustic stimuli and 28Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days. |
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| Sham modulation group | Sham Comparator | Sham stimulation was identical to the 40Hz stimulation, except that the acoustic and electric stimulation were ramped down after 0.5 min to remain turned off for the remaining 39.5 min. Sham stimuli are applied for 40min/day, for a total of 5 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-Stimulator, NeuroConn, Germany | Device | Neurostimulation device |
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| Measure | Description | Time Frame |
|---|---|---|
| Coma Recovery Scale-Revised scores | 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). | Day 1-5, Day 11-15 |
| Neuropsychological assessment | EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300). | Day 5 and Day 11 |
| Glasgow Outcome Scale-Extended | A widely used index for outcomes after brain injury | 1 year after stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benyan Luo | First Affiliated Hospital of Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital,Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30448386 | Background | Fan S, Wu X, Xie M, Li X, Liu C, Su Y, Chen Y, Wu S, Ma C. Trigeminal nerve stimulation successfully awakened an unconscious patient. Brain Stimul. 2019 Mar-Apr;12(2):361-363. doi: 10.1016/j.brs.2018.11.001. Epub 2018 Nov 3. No abstract available. |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |