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

June 2, 2024 updated by: First Affiliated Hospital of Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310003
        • Recruiting
        • First Affiliated Hospital,Zhejiang University
        • Principal Investigator:
          • Benyan Luo, Phd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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: 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
Experimental: tDCS intervention
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
Other: 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
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
Experimental: Melatonin intervention
Participants were given a 3-mg fast-release oral dose of melatonin.
Drug: Melatonin
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
Placebo Comparator: Control
Patients were treated with the placebo and sham-tDCS.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
protein metabolism
Time Frame: Change from Baseline protein metabolism at 14 days.
Changes of protein content in peripheral blood
Change from Baseline protein metabolism at 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sleep and stimulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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