tDCS in Patients With Disorders of Consciousness

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03475537

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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Condition or Disease	Intervention/Treatment	Phase
Consciousness Disorder Transcranial Direct Current Stimulation	Device: transcranial direct current stimulation	N/A

Detailed Description

Neurostimulation techniques such as deep brain stimulation (DBS) and spinal cord stimulation (SCS) have been used to treat DOC. Although these techniques have been shown to increase patient response, there are still some limitations. For example, DBS requires craniotomy and may increase the risk of intracranial hemorrhage and infection. In addition, the complexity and cost of these technologies also limit their potential applications.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Usage of tDCS in Patients With Disorders of Consciousness

Anticipated Study Start Date :

Apr 15, 2018

Anticipated Primary Completion Date :

Jul 15, 2019

Anticipated Study Completion Date :

Jan 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the treatment of transcranial direct current stimulation Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7×5 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.	Device: transcranial direct current stimulation the treatment of transcranial direct current stimulation

Arm

Intervention/Treatment

Experimental: the treatment of transcranial direct current stimulation

Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7×5 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.

Device: transcranial direct current stimulation

the treatment of transcranial direct current stimulation

Outcome Measures

Primary Outcome Measures

improvement of CRS-R [7 days]
test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with DOC: VS and MCS (the cause of unification is: traumatic brain injury, the course of more than 1 month, not more than 1 year ; age 18-65; Past history without a mental disorder; No previous alcohol or substance abuse; No epilepsy or frequent spontaneous movement; No benzodiazepines; No moderate or severe hydrocephalus, All patients were right handed.

Exclusion Criteria:

Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang	China

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

Principal Investigator: Benyan Luo, Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT03475537

Other Study ID Numbers:

test

First Posted:

Mar 23, 2018

Last Update Posted:

Oct 23, 2019

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Consciousness Disorders

Study Results

No Results Posted as of Oct 23, 2019