Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients
I-HELP
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
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJanuary 4, 2023
January 1, 2023
2.8 years
January 2, 2023
January 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Number of Participants With (Severe) Adverse Events
Number of AEs and SAEs occurring throughout the paradigm.
day 20 (+/-3)
Secondary Outcomes (2)
Hybrid Neural Network Evaluation
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
Change from baseline to 1 month
Study Arms (2)
rTMS treatment
EXPERIMENTAL20 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.
iTBS treatment
EXPERIMENTAL20 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.
Interventions
Transcranial magnetic stimulation given to the left dorsolateral prefrontal cortex
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liping Liulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liping Liu
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
March 1, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
January 4, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share