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

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05285124

Collaborator

(none)

Enrollment

Location

Arms

50.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Disorder of Consciousness	Drug: Melatonin Other: Placebo	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 22, 2020

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention of circadian rhythm After taking melatonin, HD tDCS was used for treatment, and the data before and after treatment were collected	Drug: Melatonin After taking Melatonin to interfere with circadian rhythm, HD-tDCS was used to improve participants' consciousness Other Names: HD-tDCS
Placebo Comparator: No intervention in circadian rhythm After taking placebo, patients were treated with HD tDCS, and the data before and after treatment were collected	Other: Placebo After taking placebo to interfere with circadian rhythm, HD-tDCS was used to improve participants' consciousness Other Names: HD-tDCS

Arm

Intervention/Treatment

Experimental: Intervention of circadian rhythm

After taking melatonin, HD tDCS was used for treatment, and the data before and after treatment were collected

Drug: Melatonin

After taking Melatonin to interfere with circadian rhythm, HD-tDCS was used to improve participants' consciousness

Other Names:

HD-tDCS

Placebo Comparator: No intervention in circadian rhythm

After taking placebo, patients were treated with HD tDCS, and the data before and after treatment were collected

Other: Placebo

After taking placebo to interfere with circadian rhythm, HD-tDCS was used to improve participants' consciousness

Other Names:

HD-tDCS

Outcome Measures

Primary Outcome Measures

The Coma Recovery Scale-Revised (CRS-R) scale [Change from Baseline CRS-R at 14 days.]
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.
Electroencephalography (EEG) [Change from baseline EEG power spectral density at 14 days.]
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.
Sleep parameters [Change from baseline sleep patterns at 14 days.]
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).
Resting state fMRI [Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.]
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.
Micro-expression [At baseline.]
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.

Secondary Outcome Measures

protein metabolism [Change from Baseline protein metabolism at 14 days.]
Changes of protein content in peripheral blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital,Zhejiang University	Hanzhou	Zhejiang	China	310003

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

Study Director: Benyan Luo, PhD, The First Affiliated Hospital, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT05285124

Other Study ID Numbers:

Sleep and stimulation

First Posted:

Mar 17, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by First Affiliated Hospital of Zhejiang University

disorder of consciousness

Circadian rhythm

HD-tDCS

Additional relevant MeSH terms:

Consciousness Disorders

Melatonin

Study Results

No Results Posted as of Jun 8, 2022