tDCS in Patients With Disorders of Consciousness

NCT ID: NCT03475537

Last Updated: 2019-10-23

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2020-01-15

Brief Summary

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Detailed Description

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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.

Conditions

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Consciousness Disorder Transcranial Direct Current Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

the treatment of transcranial direct current stimulation

Interventions

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transcranial direct current stimulation

the treatment of transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benyan Luo

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id

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