Ischemic Stroke Clinical Trial
— I-HELPOfficial title:
Effect of Individual Biofeedback Transcranial Magnetic Stimulation Assessed by a Hybrid Neural Network Evaluation Model on Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Liping Liu |
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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