Consciousness DisorderNCT03475537
tDCS in Patients With Disorders of Consciousness
A study testing transcranial direct current stimulation in people with Consciousness Disorder and Transcranial Direct Current Stimulation, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Consciousness Disorder, Transcranial Direct Current Stimulation
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: The Usage of tDCS in Patients With Disorders of Consciousness
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.
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
the treatment of transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of CRS-R
test
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start15 Apr 2018 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
Why it stopped: short of euqitments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, Principal investigator, Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475537
- Sponsor's protocol ID
- test
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usage of tDCS in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03475537
- Acronym / sponsor ID
- test
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: short of euqitments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the treatment of transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulationDirect 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion of organic heart disease, such as sinus bradycardia, arrhythmia; exclusion of patients with intracranial metal devices, pacemakers or any other device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationthe treatment of transcranial direct current stimulation | Device | the treatment of transcranial direct current stimulation |
Primary outcome
improvement of CRS-R
Time frame: 7 days
test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benyan Luo principal investigator
Department of Neurology and Brain Medical Centre The First Affiliated Hospital, School of Medicine, Zhejiang University 79 Qingchun Road, Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Consciousness Disorder and Transcranial Direct Current Stimulation, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of CRS-R (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.