tDCS in Patients With Disorders of Consciousness

Not Applicable

Withdrawn

• Conditions: Consciousness Disorder; Transcranial Direct Current Stimulation
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT03475537
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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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 Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-23
• Study Start: 2018-04-15
• Primary Completion: 2019-07-15
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23
• Study Completion: 2020-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
the treatment of transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
improvement of CRS-R	7 days	test

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China