HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness

Zhejiang University

Status: Enrolling

Conditions: Disorder of Consciousness

Treatments: Other: HD-tDCS; Drug: Melatonin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05285124

Sleep and stimulation

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 4 patient groups, including a placebo group

tDCS and melatonin intervention

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Other: HD-tDCS

tDCS intervention

Experimental group

Description:

In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.

Treatment:

Other: Placebo

Other: HD-tDCS

Melatonin intervention

Experimental group

Description:

Participants were given a 3-mg fast-release oral dose of melatonin.

Treatment:

Drug: Melatonin

Control

Placebo Comparator group

Description:

Patients were treated with the placebo and sham-tDCS.

Treatment:

Other: Placebo