Clinical trial NCT05285124: HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
Official title: Effect and Mechanism of HD-tDCS Combined With Circadian Rhythm Remodeling on Consciousness Recovery in Patients With Chronic Disorder of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Keywords: disorder of consciousness
Circadian rhythm
HD-tDCS
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The circadian rhythm characteristics of sleep cycle and neuroendocrine in patients with chronic disorder of consciousness show different degrees of disorder, and the relationship between this disorder and consciousness level is unclear.The researchers used HD-tDCS to treat patients with chronic disturbance of consciousness who intervened in circadian rhythm, and used a variety of methods such as EEG, fMRI, protein metabolism, ERP and micro-expression to explore the mechanism of improving the state of consciousness of HD-DCS and the relationship between circadian rhythm and patients' consciousness level

Detailed description: The sleep status (\> 24 hours) of patients with chronic disturbance of consciousness was recorded with the revised coma recovery scale revised (CRS-R) and Polysomnography (PSG). The sleep cycle of patients with chronic disturbance of consciousness was judged by the open and close eyes cycle and EEG.

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

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of disorder of consciousness
* 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:

* locked-in syndrome
* 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

Primary outcomes:
measure: The Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: Change from Baseline CRS-R at 14 days.
measure: Electroencephalography (EEG)
timeFrame: Change from baseline EEG power spectral density at 14 days.
measure: Sleep parameters
timeFrame: Change from baseline sleep patterns at 14 days.
measure: Resting state fMRI
timeFrame: Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
measure: Micro-expression
timeFrame: At baseline.
Secondary outcomes:
measure: protein metabolism
timeFrame: Change from Baseline protein metabolism at 14 days.
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: First Affiliated Hospital,Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo, PhD
role: STUDY_DIRECTOR
References: