Clinical trial NCT05670873: Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Consciousness Disorder
Transcranial Magnetic Stimulation
Keywords: Ischemic Stroke
Consciousness Disorder
Transcranial Magnetic Stimulation
Hybrid Neural Network Evaluation Model
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Coma Recovery Scale Revised (CRS-R)
timeFrame: Change in maximum CRS-R score from baseline to 1 month
measure: Number of Participants With (Severe) Adverse Events
timeFrame: day 20 (+/-3)
Secondary outcomes:
measure: Hybrid Neural Network Evaluation
timeFrame: Change from baseline to day 20 (+/-3)
measure: Number of voxels in which the Functional Magnetic Resonance Imaging (fMRI) signal is significantly associated to TMS across the whole group
timeFrame: Change from baseline to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Liping Liu
role: PRINCIPAL_INVESTIGATOR
References: