Clinical trial NCT03809936: Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Official title: Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Consciousness
Keywords: tDCS
EEG
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 33
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the JFK Coma Recovery Scale-Revised (CRS-R) scale
timeFrame: 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 outcomes:
measure: EEG data ( electrophysiological parameters)
timeFrame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Hospital of Zhejiang CAPR
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.