Disorder of ConsciousnessNCT03809936
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
A study testing real tDCS in people with Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2019to 31 Dec 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of DOC
- Ages 14 to 65 years old
- No centrally acting drugs
- No neuromuscular function blockers and no sedation within the prior 24 hours;
Who cannot join
- History with nervous or spirit disorders, or some other serious diseases
- A contraindication for tDCS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness
To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.
Read the detailed description
Background:tDCS was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.
Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tDCS in DOC.
Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
- Conditions
- Disorder of Consciousness
- Being tested
- real tDCS, sham tDCS
- Keywords
- tDCS, EEG
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tDCSDevice
Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 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.
sham tDCSDevice
For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | real tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients. Receives: Device: real tDCS |
| sham tDCS | Sham comparator | sham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
Measured: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.
Secondary outcomes (1)
EEG data ( electrophysiological parameters)
delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery.
Measured: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start2 Apr 2019
- Primary completion2 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 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, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809936
- Sponsor's protocol ID
- tDCS
- Status last verified
- Apr 2019
- First submitted
- 26 Jul 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu J, Wu Y, Wu B, Xu C, Cai J, Wen X, Meng F, Zhang L, He F, Hong L, Gao J, Li J, Yu J, Luo B. Sleep patterns correlates with the efficacy of tDCS on post-stroke patients with prolonged disorders of consciousness. J Transl Med. 2022 Dec 15;20(1):601. doi: 10.1186/s12967-022-03710-2.
PubMed 36522680Wu M, Yu Y, Luo L, Wu Y, Gao J, Ye X, Luo B. Efficiency of Repetitive Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex in Disorders of Consciousness: A Randomized Sham-Controlled Study. Neural Plast. 2019 Jun 11;2019:7089543. doi: 10.1155/2019/7089543. eCollection 2019.
PubMed 31308848
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on the Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03809936
- Acronym / sponsor ID
- tDCS
- Conditions
- Disorder of Consciousness
- Keywords
- tDCS, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Jan 2019 (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.
To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.
Detailed description
Background:tDCS was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.
Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tDCS in DOC.
Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: real tDCSreal tDCS:anodal transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients. |
| sham tDCS | Sham comparator | Device: sham tDCSsham tDCS:sham transcranial direct current stimulation were delivered over the left DLPF cortex for 20 minutes in patients. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of DOC
- Ages 14 to 65 years old
- No centrally acting drugs
- No neuromuscular function blockers and no sedation within the prior 24 hours;
Key exclusion criteria (2 listed)
- History with nervous or spirit disorders, or some other serious diseases
- A contraindication for tDCS
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 |
|---|---|---|
| real tDCSDirect current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 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 | real tDCS |
| sham tDCSFor the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down. | Device | sham tDCS |
Primary outcome
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
1 secondary outcome
EEG data ( electrophysiological parameters)
Time frame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 36522680Yu J, Wu Y, Wu B, Xu C, Cai J, Wen X, Meng F, Zhang L, He F, Hong L, Gao J, Li J, Yu J, Luo B. Sleep patterns correlates with the efficacy of tDCS on post-stroke patients with prolonged disorders of consciousness. J Transl Med. 2022 Dec 15;20(1):601. doi: 10.1186/s12967-022-03710-2.
- Derived from this study: PubMed 31308848Wu M, Yu Y, Luo L, Wu Y, Gao J, Ye X, Luo B. Efficiency of Repetitive Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex in Disorders of Consciousness: A Randomized Sham-Controlled Study. Neural Plast. 2019 Jun 11;2019:7089543. doi: 10.1155/2019/7089543. eCollection 2019.
- Individual participant dataSharing planned: No
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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
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tDCS in people with Disorder of Consciousness, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 May 2022. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the JFK Coma Recovery Scale-Revised (CRS-R) scale (time frame: at baseline (T0), immediately after the end of the treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809936, which also lists 2 linked publications.
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 27 May 2022.