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

January 2, 2023 updated by: Liping Liu

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS treatment
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.
Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation given to the left dorsolateral prefrontal cortex
Experimental: iTBS treatment
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.
Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation given to the left dorsolateral prefrontal cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale Revised (CRS-R)
Time Frame: Change in maximum CRS-R score from baseline to 1 month
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
Number of Participants With (Severe) Adverse Events
Time Frame: day 20 (+/-3)
Number of AEs and SAEs occurring throughout the paradigm.
day 20 (+/-3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hybrid Neural Network Evaluation
Time Frame: Change from baseline to day 20 (+/-3)
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)
Number of voxels in which the Functional Magnetic Resonance Imaging (fMRI) signal is significantly associated to TMS across the whole group
Time Frame: Change from baseline to 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liping Liu

Investigators

  • Principal Investigator: Liping Liu, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-HELP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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