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

Disorder of Consciousness Clinical Trial

— HD-tDCS  

Official title:

Effect and Mechanism of HD-tDCS Combined With Circadian Rhythm Remodeling on Consciousness Recovery in Patients With Chronic Disorder of Consciousness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285124
• Other study ID #: Sleep and stimulation
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Benyan Luo, PhD
• Phone: 13967166677
• Email: luobenyan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

Drug:
• Melatonin
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00

Other:
• 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

Locations

Country	Name	City	State
China	First Affiliated Hospital,Zhejiang University	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Coma Recovery Scale-Revised (CRS-R) scale	The CRS-R is a tool used to characterise the level of consciousness consisting of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The values range from 0 to 23, with higher score indicating better outcome.	Change from Baseline CRS-R at 14 days.
Primary	Electroencephalography (EEG)	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 a and ß is related to the chance of recovery.	Change from baseline EEG power spectral density at 14 days.
Primary	Sleep parameters	Changes in in sleep/wake architecture assessed by polysomnography. Electrodes attached to the scalp near the frontal, central (top) and occipital (back) portions of the brain and provide a readout of different stages of sleep (N1, N2, N3, REM, and Wakefulness).	Change from baseline sleep patterns at 14 days.
Primary	Resting state fMRI	Resting state fMRI reflects the brain activity occured in a resting or task-negative state. Regional (ReHo, ALFF, fALFF, etc.) and global parameters (functional connectivity, etc.) could be used in this study.	Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
Primary	Micro-expression	After listening to auditory stimulations, transient alterations may occur on the micro expression of the subjects. High-resolution video will be taken to capture each subject's facial micro-expressions while listening to the auditory materials.	At baseline.
Secondary	protein metabolism	Changes of protein content in peripheral blood	Change from Baseline protein metabolism at 14 days.