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Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

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ClinicalTrials.gov Identifier: NCT03809936
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Disorder of Consciousness Device: real tDCS Device: sham tDCS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : September 1, 2018

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.




Primary Outcome Measures :
  1. the JFK Coma Recovery Scale-Revised (CRS-R) scale [ Time Frame: 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 :
  1. EEG data ( electrophysiological parameters) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809936


Locations
China, Zhejiang
Hangzhou Hospital of Zhejiang CAPR
Hangzhou, Zhejiang, China
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
Principal Investigator: Benyan Luo The First Affiliated Hospital, Zhejiang University

Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03809936     History of Changes
Other Study ID Numbers: tDCS
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Zhejiang University:
tDCS
EEG

Additional relevant MeSH terms:
Disease
Consciousness Disorders
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders