Disorder of ConsciousnessNCT05820178
tDCS and rTMS in Patients With Early Disorders of Consciousness
A study testing tDCS and rTMS in people with Disorder of Consciousness and Stroke, run by Xuanwu Hospital, Beijing.
Trial summary
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Consciousness, Stroke, Ischemic-hypoxic Encephalopathy
- What is being tested?
- tDCS and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Apr 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years
- diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI)
- DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC
- 5.informed consent obtained from the patient's legal representative.
Who cannot join
- foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site)
- pacemaker or cochlear implants
- history of epilepsy and family history of epilepsy
- large cranial defects
- significant cerebral edema lesions in both DLPFC
- pregnant women
Show all 9Show fewer
- with severe physical diseases such as heart, lung, liver and kidney
- brain death
- new intracerebral lesions in patients during the study period affecting the assessment and prognosis, e.g. new stroke
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.
Read the detailed description
To study the efficacy of wakefulness promotion in patients with acute DOC due to severe non-traumatic brain injury (including stroke and ischemic-hypoxic encephalopathy), patients with early DOC were randomly divided into conventional treatment group, tDCS treatment group and rTMS treatment group for 14 consecutive days. Clinical scoring, evoked potential assessment, resting-state high-density electroencephalogram(EEG) and TMS-EEG assessment with functional analysis of brain network connectivity were applied for multidimensional assessment of brain function before and after wake-up promotion treatment (day 1 and day 15 of enrollment) to explore non-invasive brain stimulation(NIBS) techniques that can be performed at the bedside - tDCS, rTMS intervention The prognostic follow-up was performed at 3 months, 6 months and 12 months after DOC to compare the awakening rate after tDCS and rTMS prolongation treatment, and to preferably select an effective prolongation technique for early DOC. The safety of tDCS and rTMS was also clarified by comparing the differences in adverse effects and complications between tDCS treatment group and rTMS treatment group and conventional treatment group.
- Keywords
- Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation
- Medical subject headings
- Consciousness Disorders, Stroke, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
rTMSDevice
On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
| Study group | Role | What they receive |
|---|---|---|
| tDCS treatment group | Experimental | On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day. Receives: Device: tDCS |
| rTMS treatment group | Experimental | On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day. Receives: Device: rTMS |
| conventional treatment group | No intervention | Not receiving any neuromodulation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS-R
The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.
Measured: day 15 of enrollment
Secondary outcomes (10)
GCS
The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
Measured: day 15 of enrollment
FOUR
The unabbreviated scale title is full outline of unresponsiveness. The FOUR tested 4 components: eye opening response, brainstem reflex, respiratory pattern and motor response, with a total score of 0-16. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
Measured: day 15 of enrollment
MMN
The unabbreviated scale title is mismatch negative, representing an important component of auditory event-related potentials. We measure the occurrence, latency and wave amplitude of MMN.
Measured: day 15 of enrollment
MEP
The unabbreviated scale title is motor evoked potential, which can examine the overall synchronization and integrity of the motor nerve transmission and conduction pathways from the cortex to the muscle. We measure the occurrence, latency and wave amplitude of MEP.
Measured: day 15 of enrollment
ABCD model of neural oscillation
The total frequency content of the EEG is represented by a power spectrum that indicates the neural oscillations at different frequencies within the EEG signal. the ABCD model roughly classifies these changes in the EEG power spectrum into four types of ABCD, and this model is thought to reflect the severity of thalamo-cortical neural afferent block and is used to understand the different degrees of structural and functional afferent impairment present in patients with DOC. The ABCD model can reflect neural oscillations from A to D corresponding to the level of consciousness from DOC to wakefulness.
Measured: day 15 of enrollment
brain network transfer entropy
Information flow between neural networks is the basis for understanding brain signal processing and function. Using the method of transfer entropy to analyze the information flow between two two channels, the wavelet consistency algorithm was applied to reveal the linear and nonlinear correlations between regional local field potentials, and the real-time coupling relationship between two channels of neural signals in time-frequency space, including coupling strength and coupling direction. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
Measured: day 15 of enrollment
brain network phase synchronization
The synchronization relationship between two two channels was analyzed using the method of phase synchronization to form a whole-brain synchronization matrix, and the synchronization matrix was calculated to analyze the direction and strength of whole-brain network connectivity by analyzing data such as shortest path and agglomeration coefficient in the small-world network index. Brain network connectivity can be determined, and comatose patients have significantly weaker connectivity than normal whole brain.
Measured: day 15 of enrollment
Prognostic scores (mRS)
The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
Measured: 3 months, 6 months, 12 months after DOC
Prognostic scores (GOS)
The unabbreviated scale title is Glasgow Outcome Scale. GOS includes a score of 1-5, with the higher the score, the better the prognosis.
Measured: 3 months, 6 months, 12 months after DOC
Prognostic scores (CRS-R)
The unabbreviated scale title is the coma recovery scale-revised. The CRS-R includes a total score of 0-23.The lower the score, the worse the prognosis.
Measured: 3 months, 6 months, 12 months after DOC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820178
- Sponsor's protocol ID
- DOC1
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of the Efficacy of tDCS and rTMS in Promoting Wakefulness in Patients With Early Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT05820178
- Acronym / sponsor ID
- DOC1
- Keywords
- Transcranial Direct Current Stimulation, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Apr 2023 (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.
A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.
Detailed description
To study the efficacy of wakefulness promotion in patients with acute DOC due to severe non-traumatic brain injury (including stroke and ischemic-hypoxic encephalopathy), patients with early DOC were randomly divided into conventional treatment group, tDCS treatment group and rTMS treatment group for 14 consecutive days. Clinical scoring, evoked potential assessment, resting-state high-density electroencephalogram(EEG) and TMS-EEG assessment with functional analysis of brain network connectivity were applied for multidimensional assessment of brain function before and after wake-up promotion treatment (day 1 and day 15 of enrollment) to explore non-invasive brain stimulation(NIBS) techniques that can be performed at the bedside - tDCS, rTMS intervention The prognostic follow-up was performed at 3 months, 6 months and 12 months after DOC to compare the awakening rate after tDCS and rTMS prolongation treatment, and to preferably select an effective prolongation technique for early DOC. The safety of tDCS and rTMS was also clarified by comparing the differences in adverse effects and complications between tDCS treatment group and rTMS treatment group and conventional treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS treatment group | Experimental | Device: tDCSOn the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day. |
| rTMS treatment group | Experimental | Device: rTMSOn the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day. |
| conventional treatment group | No intervention | –Not receiving any neuromodulation treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-80 years
- diagnosis of stroke or ischemic-hypoxic encephalopathy confirmed by neuroimaging (head MRI)
- DOC, Glasgow coma score (GCS) <12 4.2-4 weeks of DOC
- 5.informed consent obtained from the patient's legal representative.
Key exclusion criteria (9 listed)
- foreign bodies such as metal or electronic devices in the skull (inside or on the surface of the tissue at the treatment stimulation site)
- pacemaker or cochlear implants
- history of epilepsy and family history of epilepsy
- large cranial defects
- significant cerebral edema lesions in both DLPFC
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 |
|---|---|---|
| tDCSOn the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day. | Device | tDCS treatment group |
| rTMSOn the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day. | Device | rTMS treatment group |
Primary outcome
CRS-R
Time frame: day 15 of enrollment
The unabbreviated scale title is the coma recovery scale-revised.The CRS-R tests six components: auditory, language, visual, communication, motor and arousal levels, with a total score of 0-23. The lower the score, the more severe the brain damage and the deeper the DOC level.
10 secondary outcomes
GCS
Time frame: day 15 of enrollment
FOUR
Time frame: day 15 of enrollment
MMN
Time frame: day 15 of enrollment
MEP
Time frame: day 15 of enrollment
ABCD model of neural oscillation
Time frame: day 15 of enrollment
brain network transfer entropy
Time frame: day 15 of enrollment
brain network phase synchronization
Time frame: day 15 of enrollment
Prognostic scores (mRS)
Time frame: 3 months, 6 months, 12 months after DOC
Prognostic scores (GOS)
Time frame: 3 months, 6 months, 12 months after DOC
Prognostic scores (CRS-R)
Time frame: 3 months, 6 months, 12 months after DOC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: Yes. study protocol can be shared.
Related trials for Disorder of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
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.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and rTMS in people with Disorder of Consciousness and Stroke, run by Xuanwu Hospital, Beijing.
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 9 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Zhang, MD (0086-13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS-R (time frame: day 15 of enrollment). 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 26 Apr 2023.