Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Not Applicable

Completed

• Conditions: Disorder of Consciousness
• Interventions: Device: real tDCS; Device: sham tDCS

• Registration Number: NCT03809936
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.

Detailed Description

Background:tDCS was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.

Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tDCS in DOC.

Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Status Verified: 2019-04
• Study Start: 2019-04-02
• Primary Completion: 2020-01-02
• Study Completion: 2020-12-31
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Clinical diagnosis of DOC
2. Ages 14 to 65 years old
3. No centrally acting drugs
4. No neuromuscular function blockers and no sedation within the prior 24 hours;

Exclusion Criteria

1. History with nervous or spirit disorders, or some other serious diseases
2. A contraindication for tDCS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real tDCS	real tDCS	real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.
sham tDCS	sham tDCS	sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.

Primary Outcome Measures

Name	Time	Method
the JFK Coma Recovery Scale-Revised (CRS-R) scale	at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.	The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

Secondary Outcome Measures

Name	Time	Method
EEG data ( electrophysiological parameters)	at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).	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.

Trial Locations

Locations (1)

Hangzhou Hospital of Zhejiang CAPR; 🇨🇳 Hangzhou, Zhejiang, China