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

NCT05285124 | Recruiting DMC

• 1 other identifier: Sleep and stimulation
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Disorder of Consciousness

Keywords

disorder of consciousness; Circadian rhythm; HD-tDCS

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

  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).

  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.

  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.

  At baseline.

Secondary Outcomes (1)

• protein metabolism

  Change from Baseline protein metabolism at 14 days.

Study Arms (4)

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.

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.

Other: Placebo; Other: HD-tDCS

Melatonin intervention

EXPERIMENTAL

Participants were given a 3-mg fast-release oral dose of melatonin.

Drug: Melatonin

Control

PLACEBO COMPARATOR

Patients were treated with the placebo and sham-tDCS.

Other: Placebo

Interventions

Melatonin DRUG

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

Melatonin intervention; tDCS and melatonin intervention

Placebo OTHER

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

Control; tDCS intervention

HD-tDCS OTHER

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

tDCS and melatonin intervention; tDCS intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital,Zhejiang University

Hanzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39627786 DERIVED

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Benyan Luo, PhD

  The First Affiliated Hospital, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Benyan Luo, PhD

CONTACT

13967166677; luobenyan@zju.edu.cn

Fangping He, MS

CONTACT

13819114225; hefangping@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: March 17, 2022
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)