Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients (I-HELP)

Liping Liu

Status: Not yet enrolling

Conditions: Ischemic Stroke; Consciousness Disorder; Transcranial Magnetic Stimulation

Treatments: Device: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05670873

I-HELP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

rTMS treatment

Experimental group

Description:

20 days of repetitive transcranial magnetic stimulation: stimulation site is the left dorsolateral prefrontal cortex, stimulation intensity at 90% RMT, stimulation frequency is 10Hz. A total of 1000 pulses, 10s 10Hz train stimulation, repeated 10 times, each interval 60s, a total of 11 minutes and 40 seconds, 1 treatment per day, a total of 20 days.

Treatment:

Device: Transcranial magnetic stimulation

iTBS treatment

Experimental group

Description:

20 days of intermittent theta-burst stimulation: stimulation site is the left dorsolateral prefrontal cortex, stimulation intensity at 90% RMT, stimulation frequency is 50Hz. A total of 600 pulses, 3 pulses each time, with an interval of 200 ms, for a total of 2 seconds (10 groups), and then repeat the above process after an interval of 10 seconds, a total of 190 seconds, 1 treatment per day, a total of 20 days.

Treatment:

Device: Transcranial magnetic stimulation