Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients

Ischemic Stroke Clinical Trial

— I-HELP  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05670873
• Other study ID #: I-HELP
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Consciousness Disorder
• Consciousness Disorders
• Disease
• Ischemic Stroke
• Transcranial Magnetic Stimulation

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