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

NCT05285124 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-06-04

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Benyan Luo, PhD · The First Affiliated Hospital, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285124 on ClinicalTrials.gov