An interventional study of tDCS and rTMS in Disorder of Consciousness, Stroke and Ischemic-hypoxic Encephalopathy, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 120 is above the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
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5. obtained from the patient's legal representative.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
Device: tDCS
On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
Device: rTMS
Not receiving any neuromodulation treatment.
On the basis of conventional treatment, tDCS was given on day 2 after enrollment for a total of 14 days, once a day.
On the basis of conventional treatment, rTMS was given on day 2 after enrollment for a total of 14 days, once a day.
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.
Time frame: day 15 of enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months, 6 months, 12 months after DOC
No study locations are listed for this record.
Plan to share: Yes — study protocol can be shared.
Supporting information: Study protocol
Time frame: after Dec 2023, always
Access criteria: email to authors
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Apr 2026, 35 months later.
Of 89 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 35 months is above that.
Counting every sponsor, half of 94 studies reached it within 19 months; a quarter within 8 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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