Disorder of ConsciousnessHD-tDCSNCT05285124
HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
A study testing Melatonin and HD-tDCS in people with Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Melatonin and HD-tDCS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital,Zhejiang University
Hanzhou, Zhejiang, 310003
Qisheng Cheng, BA, 15868500818, edisoncqis@163.com
Benyan Luo, PhD
About this study
Official title: 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
Read the 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
- Conditions
- Disorder of Consciousness
- Being tested
- Melatonin, Placebo, HD-tDCS
- Keywords
- disorder of consciousness, Circadian rhythm, HD-tDCS
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Participants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00
PlaceboOther
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-tDCSOther
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
| Study group | Role | What they receive |
|---|---|---|
| tDCS and melatonin intervention | Experimental | 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. Receives: Drug: Melatonin; Other: HD-tDCS |
| tDCS intervention | Experimental | In real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. Receives: Other: Placebo; Other: HD-tDCS |
| Melatonin intervention | Experimental | Participants were given a 3-mg fast-release oral dose of melatonin. Receives: Drug: Melatonin |
| Control | Placebo comparator | Patients were treated with the placebo and sham-tDCS. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline CRS-R at 14 days.
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.
Measured: Change from baseline EEG power spectral density at 14 days.
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).
Measured: Change from baseline sleep patterns at 14 days.
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.
Measured: Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
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.
Measured: At baseline.
Secondary outcomes (1)
protein metabolism
Changes of protein content in peripheral blood
Measured: Change from Baseline protein metabolism at 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jul 2021
- Primary completion31 Dec 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, PhD, Study director, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285124
- Sponsor's protocol ID
- Sleep and stimulation
- Acronym
- HD-tDCS
- Status last verified
- Apr 2024
- First submitted
- 17 May 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen X, Yu J, Zhu G, Wang J, Sun Y, Zhou J, Cai J, Meng F, Ling Y, Sun Y, Zhao J, He F, Cheng Q, Xu C, Gao J, Li J, Luo B. Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial. BMC Med. 2024 Dec 3;22(1):576. doi: 10.1186/s12916-024-03793-2.
PubMed 39627786
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of HD-tDCS Combined With Circadian Rhythm Remodeling on Consciousness Recovery in Patients With Chronic Disorder of Consciousness
- ClinicalTrials.gov ID
- NCT05285124
- Acronym / sponsor ID
- HD-tDCS / Sleep and stimulation
- Conditions
- Disorder of Consciousness
- Keywords
- disorder of consciousness, Circadian rhythm, HD-tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS and melatonin intervention | Experimental | Drug: Melatonin, Other: HD-tDCSIn 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. |
| tDCS intervention | Experimental | Other: Placebo, Other: HD-tDCSIn real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes. |
| Melatonin intervention | Experimental | Drug: MelatoninParticipants were given a 3-mg fast-release oral dose of melatonin. |
| Control | Placebo comparator | Other: PlaceboPatients were treated with the placebo and sham-tDCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants assigned to the melatonin group were given a 3-mg fast-release oral dose of melatonin administered at approximately 21:00 | Drug | Melatonin intervention, tDCS and melatonin intervention |
| PlaceboParticipants 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 | Other | Control, tDCS intervention |
| HD-tDCSDirect 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 | tDCS and melatonin intervention, tDCS intervention |
Primary outcome
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.
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.
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).
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.
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.
1 secondary outcome
protein metabolism
Time frame: Change from Baseline protein metabolism at 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 39627786Wen X, Yu J, Zhu G, Wang J, Sun Y, Zhou J, Cai J, Meng F, Ling Y, Sun Y, Zhao J, He F, Cheng Q, Xu C, Gao J, Li J, Luo B. Efficacy of melatonin for prolonged disorders of consciousness: a double-blind, randomized clinical trial. BMC Med. 2024 Dec 3;22(1):576. doi: 10.1186/s12916-024-03793-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benyan Luo, PhD study director
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and HD-tDCS in people with Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benyan Luo, PhD (13967166677, luobenyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Coma Recovery Scale-Revised (CRS-R) scale (time frame: Change from Baseline CRS-R at 14 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.