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In recent years, many literatures have reported that tACS, as a non-invasive electrical brain stimulation technique, has been applied in depression, schizophrenia, dementia and other fields.
The goal of this study is to explore the clinical efficacy and mechanism of action of HD-tACS in patients with chronic disorders of consciousness.The main questions it aims to answer are:
Background: tACS is a transcranial nerve regulation technique ,it has been applied in depression, schizophrenia, dementia and other fields. However, the exact mechanism of tACS has not been fully elucidated, and there are few reports about the effect of tACS stimulation on patients with consciousness disorder at home and abroad.
Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of HD-tACS in patients with chronic disorders of consciousness.
Method: Based on inclusion and exclusion criteria, patients with disorders of consciousness are categorized into chronic coma, vegetative state (VS), and minimally conscious state (MCS) groups. General and clinical data of the patients are collected. Assessments using the CRS-R scale and resting-state EEG are conducted before and after the trial. The trial is designed as a randomized controlled experiment, divided into an HD-tACS real stimulation group and a sham stimulation group. In the real stimulation group, different frequencies (40Hz gamma, 4Hz theta) of stimulation are applied to the left dorsolateral prefrontal cortex, with a current intensity of 2mA for 20 minutes per day, continuously for 5 days. In the sham stimulation group, the tACS stimulation mode and frequency are consistent with the real stimulation group, but current is only passed during the first and last 30 seconds of the entire 20-minute stimulation period. EEG is collected for all patients before stimulation, on the first day of stimulation, and after the stimulation ends. Follow-ups include CRS-R scale and GOS-E scores after 3 months and GOS-E scores after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial electrical stimulation HD-tES | Active Comparator | real HD-tACS:anodal transcranial alternating current stimulation were delivered over the left DLPF cortex for patients in different frequencies (40Hz gamma, 4Hz theta) , with a current intensity of 2mA for 20 minutes per day. |
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| sham Transcranial electrical stimulation HD-tES | Sham Comparator | sham HD-tACS: sham transcranial alternating current stimulation were delivered over the left DLPF cortex for patients in different frequencies (40Hz gamma, 4Hz theta) , with a current intensity of 2mA for 20 minutes per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real transcranial alternating current stimulation | Device | The alternating current was non-invasively delivered using an M×N five-channel high-definition transcranial electrical current stimulator (Soterix Medical). A BrainCap (Brain Vision) embedded with high-definition plastic holders consisted of five 12-mm-diameter Ag/AgCl ring electrodes, filled with conductive gel. During real HD-tACS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The primary outcome measure is the change in the CRS-R scale in patients with prolonged Disorders of Consciousness (pDoC) after 5 days of HD-tACS treatment.The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors | at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2).Investigators observed the changes from baseline to the end of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| EEG data ( electrophysiological parameters) | delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery. | at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale-Extended (GOS-E) | GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing brain injury. It has eight categories:Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper ModerateDisability, Lower Good Recovery, and Upper Good Recovery.Percentage of patients with improved consciousness (GOS-E score improved by 1 point or more) three months after stimulation ended. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Hu | Contact | 0571-87235859 | 18788432767@163.com | |
| Benyan Luo, Dr | Contact | 0571-87235859 | luobenyan@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Benyan Luo, Prof, Dr | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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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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Using a sham-controlled randomized double-blind design, 64 patients were randomly assigned to either a real or sham stimulation group. In the real stimulation group, stimulation of different frequencies (40Hz gamma, 4Hz theta) is applied to the left dorsolateral prefrontal cortex with a current intensity of 2mA for 20 minutes each day, continuously for 5 days. In the sham stimulation group, the tACS stimulation mode and frequency are the same as in the real stimulation group, but current is only applied during the first and last 30 seconds of the entire 20-minute stimulation period.
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| sham transcranial alternating current stimulation | Device | For the sham condition(sham HD-tACS), the same electrode placement was used as in the stimulation condition, but the current was only applied during the first and last 30 seconds of the entire 20-minute stimulation period. |
|
| In the first and third months after the stimulus ends |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |