Back to resultsHD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness (HD-tDCS)
Primary Purpose
Disorder of Consciousness
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Melatonin
Placebo
HD-tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Disorder of Consciousness focused on measuring disorder of consciousness, Circadian rhythm, HD-tDCS
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
Sites / Locations
- First Affiliated Hospital,Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
tDCS and melatonin intervention
tDCS intervention
Melatonin intervention
Control
Arm 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.
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.
Patients were treated with the placebo and sham-tDCS.
Outcomes
Primary Outcome Measures
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.
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 α and β is related to the chance of recovery.
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).
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.
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.
Secondary Outcome Measures
protein metabolism
Changes of protein content in peripheral blood
Full Information
NCT ID
NCT05285124
First Posted
May 17, 2021
Last Updated
September 28, 2022
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05285124
Brief Title
HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
disorder of consciousness, Circadian rhythm, HD-tDCS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS and melatonin intervention
Arm Type
Experimental
Arm 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.
Arm Title
tDCS intervention
Arm Type
Experimental
Arm Description
In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
Arm Title
Melatonin intervention
Arm Type
Experimental
Arm Description
Participants were given a 3-mg fast-release oral dose of melatonin.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients were treated with the placebo and sham-tDCS.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
HD-tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
The Coma Recovery Scale-Revised (CRS-R) scale
Description
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.
Time Frame
Change from Baseline CRS-R at 14 days.
Title
Electroencephalography (EEG)
Description
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.
Time Frame
Change from baseline EEG power spectral density at 14 days.
Title
Sleep parameters
Description
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).
Time Frame
Change from baseline sleep patterns at 14 days.
Title
Resting state fMRI
Description
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.
Time Frame
Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
Title
Micro-expression
Description
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.
Time Frame
At baseline.
Secondary Outcome Measure Information:
Title
protein metabolism
Description
Changes of protein content in peripheral blood
Time Frame
Change from Baseline protein metabolism at 14 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benyan Luo, PhD
Phone
13967166677
Email
luobenyan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fangping He, MS
Phone
13819114225
Email
hefangping@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benyan Luo, PhD
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital,Zhejiang University
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qisheng Cheng, BA
Phone
15868500818
Email
edisoncqis@163.com
First Name & Middle Initial & Last Name & Degree
Benyan Luo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
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