Disorder of ConsciousnessNCT03385278
Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness
A study testing rTMS in people with Disorder of Consciousness, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the… Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- rTMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Feb 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients ages 14 to 65 years old;
- no centrally acting drugs;
- no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);
- 5.DOC patients, including vegetative state and minimally consciousness state.
Who cannot join
- History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- with a contraindication for rTMS
Trial locations and contacts
1 site in 1 country.
Min Wu contact
Benyan Luo contact
China1 site, 1 recruiting
- Recruiting
Hangzhou Hospital of Zhejiang CAPR
Hangzhou, Zhejiang
Min Wu, 18826401709@163.com
Kehong Liu
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness
Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.
Read the detailed description
Background:Repetitive transcranial magnetic stimulation (rTMS) 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 high-frequency rTMS in DOC.
Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
Hypothesis:Real rTMS can be an effective awakening method.
- Conditions
- Disorder of Consciousness
- Being tested
- rTMS
- Keywords
- TMS;DOC
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
20HZ Repetitive Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| real-sham | Experimental | the group first received real rTMS,then sham one. Receives: Other: rTMS |
| sham-real | Experimental | the group first received sham rTMS,then real one. Receives: Other: rTMS |
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 5-day 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 5-day 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 posted28 Dec 2017
- Study startApr 2015
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Model description
- This study was designed and performed as a randomized, controlled cross-over trial. All patients were randomly received active 20-Hz rTMS and sham stimulation for 5 consecutive days, in separate sessions spaced one week.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
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
- NCT03385278
- Sponsor's protocol ID
- TMS
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cincotta M, Giovannelli F, Chiaramonti R, Bianco G, Godone M, Battista D, Cardinali C, Borgheresi A, Sighinolfi A, D'Avanzo AM, Breschi M, Dine Y, Lino M, Zaccara G, Viggiano MP, Rossi S. No effects of 20 Hz-rTMS of the primary motor cortex in vegetative state: A randomised, sham-controlled study. Cortex. 2015 Oct;71:368-76. doi: 10.1016/j.cortex.2015.07.027. Epub 2015 Aug 4.
PubMed 26301875Xu C, Hu J, Wu Q, Wu M, Yu Y, Li H, Gao J, Li J, Ding N, Yu J, Luo B. Efficacy of Intermittent Theta-Burst Stimulation for Prolonged Disorders of Consciousness: A Prospective, Randomized, Controlled Trial. Ann Clin Transl Neurol. 2026 Aug;13(8):1619-1627. doi: 10.1002/acn3.70342. Epub 2026 Feb 19.
PubMed 41714857He F, Wu M, Meng F, Hu Y, Gao J, Chen Z, Bao W, Liu K, Luo B, Pan G. Effects of 20 Hz Repetitive Transcranial Magnetic Stimulation on Disorders of Consciousness: A Resting-State Electroencephalography Study. Neural Plast. 2018 Mar 25;2018:5036184. doi: 10.1155/2018/5036184. eCollection 2018.
PubMed 29770146
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03385278
- Acronym / sponsor ID
- TMS
- Conditions
- Disorder of Consciousness
- Keywords
- TMS;DOC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 28 Dec 2017 (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.
Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.
Detailed description
Background:Repetitive transcranial magnetic stimulation (rTMS) 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 high-frequency rTMS in DOC.
Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.
Hypothesis:Real rTMS can be an effective awakening method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed and performed as a randomized, controlled cross-over trial. All patients were randomly received active 20-Hz rTMS and sham stimulation for 5 consecutive days, in separate sessions spaced one week.
| Arm | Type | Receives |
|---|---|---|
| real-sham | Experimental | Other: rTMSthe group first received real rTMS,then sham one. |
| sham-real | Experimental | Other: rTMSthe group first received sham rTMS,then real one. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ages 14 to 65 years old;
- no centrally acting drugs;
- no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);
- 5.DOC patients, including vegetative state and minimally consciousness state.
Key exclusion criteria (2 listed)
- History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- with a contraindication for rTMS
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 |
|---|---|---|
| rTMS20HZ Repetitive Transcranial Magnetic Stimulation | Other | real-sham, sham-real |
Primary outcome
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: at baseline (T0), immediately after the end of the 5-day 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 5-day treatment (T1), 1 week later (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Background: PubMed 26301875Cincotta M, Giovannelli F, Chiaramonti R, Bianco G, Godone M, Battista D, Cardinali C, Borgheresi A, Sighinolfi A, D'Avanzo AM, Breschi M, Dine Y, Lino M, Zaccara G, Viggiano MP, Rossi S. No effects of 20 Hz-rTMS of the primary motor cortex in vegetative state: A randomised, sham-controlled study. Cortex. 2015 Oct;71:368-76. doi: 10.1016/j.cortex.2015.07.027. Epub 2015 Aug 4.
- Derived from this study: PubMed 41714857Xu C, Hu J, Wu Q, Wu M, Yu Y, Li H, Gao J, Li J, Ding N, Yu J, Luo B. Efficacy of Intermittent Theta-Burst Stimulation for Prolonged Disorders of Consciousness: A Prospective, Randomized, Controlled Trial. Ann Clin Transl Neurol. 2026 Aug;13(8):1619-1627. doi: 10.1002/acn3.70342. Epub 2026 Feb 19.
- Derived from this study: PubMed 29770146He F, Wu M, Meng F, Hu Y, Gao J, Chen Z, Bao W, Liu K, Luo B, Pan G. Effects of 20 Hz Repetitive Transcranial Magnetic Stimulation on Disorders of Consciousness: A Resting-State Electroencephalography Study. Neural Plast. 2018 Mar 25;2018:5036184. doi: 10.1155/2018/5036184. eCollection 2018.
- 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.
Min Wu contact
Benyan Luo contact
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 rTMS 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: status not confirmed, as of the sponsor's last update on 28 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Wu (18826401709@163.com), or a site near the patient. 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 5-day 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 NCT03385278, which also lists 3 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 28 Dec 2017.