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tDCS in Patients With Disorders of Consciousness

Primary Purpose

Consciousness Disorder, Transcranial Direct Current Stimulation

Status

Withdrawn

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Consciousness Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

The First Affiliated Hospital, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the treatment of transcranial direct current stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

improvement of CRS-R

test

Secondary Outcome Measures

Full Information

NCT ID

NCT03475537

First Posted

March 18, 2018

Last Updated

October 21, 2019

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03475537

Brief Title

tDCS in Patients With Disorders of Consciousness

Official Title

The Usage of tDCS in Patients With Disorders of Consciousness

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

short of euqitments

Study Start Date

April 15, 2018 (Anticipated)

Primary Completion Date

July 15, 2019 (Anticipated)

Study Completion Date

January 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

test

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Consciousness Disorder, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

the treatment of transcranial direct current stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

the treatment of transcranial direct current stimulation

Primary Outcome Measure Information:

Title

improvement of CRS-R

Description

test

Time Frame

7 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benyan Luo

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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tDCS in Patients With Disorders of Consciousness

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