Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorder of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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real tDCS

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

Group Type ACTIVE_COMPARATOR

real tDCS

Intervention Type DEVICE

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 tDCS

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

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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;