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NCT03475537 Clinical Trial

tDCS in Patients With Disorders of Consciousness

Transcranial Direct Current Stimulation Clinical Trial

Official title:
The Usage of tDCS in Patients With Disorders of Consciousness

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03475537
Other study ID # test
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date January 15, 2020

Study information
Verified date March 2018
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

test

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 15, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• transcranial direct current stimulation
the treatment of transcranial direct current stimulation

Locations
Country Name City State
China The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary improvement of CRS-R test 7 days
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