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WithdrawnNCT03475537Updated Oct 23, 2019

tDCS in Patients With Disorders of Consciousness

An interventional study of transcranial direct current stimulation in Consciousness Disorder and Transcranial Direct Current Stimulation, sponsored by First Affiliated Hospital of Zhejiang University. Withdrawn at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
short of euqitments
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

test

Read the 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.

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Conditions studied

  • Consciousness Disorder
  • Transcranial Direct Current Stimulation
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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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 Criteria:

Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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.

    Device: transcranial direct current stimulation

Interventions

  • Devicetranscranial direct current stimulation

    the treatment of transcranial direct current stimulation

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What researchers measure

Primary outcomes

  1. improvement of CRS-R

    test

    Time frame: 7 days

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Study locations

1 site
  • The First Affiliated Hospital, Zhejiang University
    Hangzhou, Zhejiang, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03475537
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Apr 15, 2018 (estimated)
Primary completion
Jul 15, 2019 (estimated)
Completion
Jan 15, 2020 (estimated)
Last update
Oct 23, 2019

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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