Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Device: real tDCS; Device: sham 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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou Hospital of Zhejiang CAPR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real tDCS; real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.	Device: real tDCS; Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
Sham Comparator: sham tDCS; sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients.	Device: sham tDCS; For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the JFK Coma Recovery Scale-Revised (CRS-R) scale	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG data ( electrophysiological parameters)	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.	at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Publications and helpful links

General Publications

• Wu M, Yu Y, Luo L, Wu Y, Gao J, Ye X, Luo B. Efficiency of Repetitive Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex in Disorders of Consciousness: A Randomized Sham-Controlled Study. Neural Plast. 2019 Jun 11;2019:7089543. doi: 10.1155/2019/7089543. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: tDCS; EEG
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: tDCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No