NCT03475537

Brief Summary

test

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

October 23, 2019

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 18, 2018

Last Update Submit

October 21, 2019

Conditions

Consciousness DisorderTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • improvement of CRS-R

    test

    7 days

Study Arms (1)

the treatment of transcranial direct current stimulation

EXPERIMENTAL

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

Interventions

transcranial direct current stimulationDEVICE

the treatment of transcranial direct current stimulation

the treatment of transcranial direct current stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Benyan Luo

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 23, 2018

Study Start

April 15, 2018

Primary Completion

July 15, 2019

Study Completion

January 15, 2020

Last Updated

October 23, 2019

Record last verified: 2018-03

Locations

CN(1)