Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809936
• Other study ID #: tDCS
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

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 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.

Locations

Country	Name	City	State
China	Hangzhou Hospital of Zhejiang CAPR	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 a and ß is related to the chance of recovery.	at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).