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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05670873
Other study ID # I-HELP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 1, 2026

Study information

Verified date January 2023
Source Beijing Tiantan Hospital
Contact Jingyi Liu
Phone 15210721213
Email jennyliu1992@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.


Description:

Despite continued advances in life-sustaining intensive care for severe brain injury patients, little can be done to promote behavioral recovery in patients with disorder of consciousness (DoC). Arousal is the primary task in the rehabilitation of patients with impaired consciousness. Evidence suggests that some medications and physical therapies can induce wakefulness by reactivating specific pathways that lead to impaired consciousness. However, due to the complexity of the type, degree, location, and other related influencing factors of brain injury, the current commonly used treatment options are not effective for patients with impaired consciousness, and the theoretical basis for benefit is not sufficient. This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC. Before and after a course of treatment (20 days), activation and connectivity of patients' arousal centers will be assessed through a hybrid neural network evaluation model, which consists of comprehensive cortical connectivity parameters (perturbational complexity index and evoked high-frequency oscillations) and region-specific cortical connectivity parameters (short-latency afferent inhibition and mismatch negativity). Each parameter is clinically used to assess a patient's level of cortex connectivity. This hybrid evaluation model may give a comprehensive evaluation of a patient's degree of awareness, and enhance our understanding of the mechanisms underlying these conditions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 7-28 days after ischemic stroke - behavioral profile consistent with a UWS or MCS as assessed with the Coma Recovery Scale Revise - prestroke Modified Ranking Scale(mRS) =2 Exclusion Criteria: - history of vascular malformation or aneurysmal SAH or untreated aneurysm prior to stroke - disorder of consciousness prior to stroke - impairment of hearing - metal implants, e.g. stenting, pacemaker, etc. - contraindications to MRI, such as claustrophobia - history of epilepsy or epileptic episodes - suffering from serious diseases such as malignant tumors, etc., with expected survival time <1 year - patient is currently involved with other trials

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial magnetic stimulation
Transcranial magnetic stimulation given to the left dorsolateral prefrontal cortex

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Liping Liu

Outcome

Type Measure Description Time frame Safety issue
Primary Coma Recovery Scale Revised (CRS-R) The Coma Recovery Scale Revised (CRS-R) is a standard clinical protocol specifically developed to assess a patient's level of consciousness, and does so by evaluating a patient's level of responsiveness to sensory stimulation, their ability to understand language, and to communicate. This procedure is typically administered at bedside. The protocol is divided into 6 sub-scales, each assessing a different area (e.g., visual function, auditory function, communication, arousal), and the final score is calculating by adding all sub-scales.The total score of this scale goes from its minimum, 0, which implied a state of coma, to 23, which implies emergence from a Minimally Conscious State (i.e., eMCS). Higher values thus map onto better outcomes. Change in maximum CRS-R score from baseline to 1 month
Primary Number of Participants With (Severe) Adverse Events Number of AEs and SAEs occurring throughout the paradigm. day 20 (+/-3)
Secondary Hybrid Neural Network Evaluation The Hybrid Neural Network Evaluation Model consists of comprehensive cortical connectivity parameters (perturbational complexity index and evoked high-frequency oscillations) and region-specific cortical connectivity parameters (short-latency afferent inhibition and mismatch negativity). Each parameter is clinically used to assess a patient's level of cortex connectivity. This hybrid evaluation model may give a comprehensive evaluation of a patient's degree of awareness, and enhance our understanding of the mechanisms underlying these conditions Change from baseline to day 20 (+/-3)
Secondary Number of voxels in which the Functional Magnetic Resonance Imaging (fMRI) signal is significantly associated to TMS across the whole group Number of voxels found to have a functional MRI signal (measured with a Blood Oxygenation Level Dependent sequence) significantly associated with the TMS stimulation across the tested population. Change from baseline to 1 month
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