HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
NCT ID: NCT05285124
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2021-07-01
2024-12-31
Brief Summary
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Detailed Description
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Patients with circadian rhythm treated with or without blue light stimulation and melatonin were treated with HD-tDCS. EEG, fMRI, protein metabolism, ERP and micro expression data were recorded before and after treatment.Explore the mechanism of improving the state of consciousness of HD-DCS and the relationship between circadian rhythm and patients' consciousness level
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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tDCS and melatonin intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. Participants were given a 3-mg fast-release oral dose of melatonin.
Melatonin
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
HD-tDCS
Direct current was applied using a battery-driven constant-current stimulator through saline-soaked surface sponge electrodes (7cm×5cm) with the anode placed over the left DLPFC (F3 according to the 10-20 international EEG system) and the reference cathode placed over the right supraorbital region (Fp2). During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes
tDCS intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
Placebo
Participants in this group were treated according to a protocol identical to those receiving active medication at approximately 21:00. For the sham tDCS groups, the same stimulation parameters were employed, except that the stimulator had a built-in placebo mode; when it was activated, two ramp fade-in/fade-out periods in the beginning and the end of sham stimulation mimicked the somatosensory artifact of real tDCS
HD-tDCS
Direct current was applied using a battery-driven constant-current stimulator through saline-soaked surface sponge electrodes (7cm×5cm) with the anode placed over the left DLPFC (F3 according to the 10-20 international EEG system) and the reference cathode placed over the right supraorbital region (Fp2). During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes
Melatonin intervention
Participants were given a 3-mg fast-release oral dose of melatonin.
Melatonin
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
Control
Patients were treated with the placebo and sham-tDCS.
Placebo
Participants in this group were treated according to a protocol identical to those receiving active medication at approximately 21:00. For the sham tDCS groups, the same stimulation parameters were employed, except that the stimulator had a built-in placebo mode; when it was activated, two ramp fade-in/fade-out periods in the beginning and the end of sham stimulation mimicked the somatosensory artifact of real tDCS
Interventions
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Melatonin
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
Placebo
Participants in this group were treated according to a protocol identical to those receiving active medication at approximately 21:00. For the sham tDCS groups, the same stimulation parameters were employed, except that the stimulator had a built-in placebo mode; when it was activated, two ramp fade-in/fade-out periods in the beginning and the end of sham stimulation mimicked the somatosensory artifact of real tDCS
HD-tDCS
Direct current was applied using a battery-driven constant-current stimulator through saline-soaked surface sponge electrodes (7cm×5cm) with the anode placed over the left DLPFC (F3 according to the 10-20 international EEG system) and the reference cathode placed over the right supraorbital region (Fp2). During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes
Eligibility Criteria
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Inclusion Criteria
* Stable vital signs
* Good coordination, less spontaneous activity
* No anti-epileptic and sedative drugs taken within prior 24 hours
* The family members volunteered and signed the informed consent
Exclusion Criteria
* Diseases and factors that may affect the judgment of brain function, such as metabolic diseases, poisoning, shock, etc.
* There are contraindications to MRI scanning, such as the presence of metal implants in the body
* Contraindications treated by transcranial direct current stimulation
18 Years
80 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Benyan Luo, PhD
Role: STUDY_DIRECTOR
The First Affiliated Hospital, Zhejiang University
Locations
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First Affiliated Hospital,Zhejiang University
Hanzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wen X, Yu J, Zhu G, Wang J, Sun Y, Zhou J, Cai J, Meng F, Ling Y, Sun Y, Zhao J, He F, Cheng Q, Xu C, Gao J, Li J, Luo B. Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial. BMC Med. 2024 Dec 3;22(1):576. doi: 10.1186/s12916-024-03793-2.
Other Identifiers
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Sleep and stimulation
Identifier Type: -
Identifier Source: org_study_id
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