Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

NCT06097013

Disorder of Consciousness

ENROLLING_BY_INVITATION

Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging

NCT06469827

Traumatic Brain Injury

RECRUITING

Acupuncture for Mild Traumatic Brain Injury：A Functional Magnetic Resonance Imaging Study

NCT02868671

Acupuncture Mild Traumatic Brain Injury MRI

COMPLETED NA

Brain Network Characteristics in Patients With Disorders of Consciousness

NCT05558670

Disorders of Consciousness

UNKNOWN

Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging

NCT05020301

Meditation Mindfulness

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Analyzed the EEG activity and brain network changes before and after stimulation by TMS stimulation of key brain regions, and correlated them with brain function. To verify the "time-frequency-space" neural mechanism of consciousness.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorder of Consciousness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real rTMS group

True rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 10 days;

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type DEVICE

Transcranial magnetic stimulation

Sham rTMS group

sham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation

Group Type PLACEBO_COMPARATOR

Sham Transcranial magnetic stimulation

Intervention Type DEVICE

Sham Transcranial magnetic stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial magnetic stimulation

Intervention Type DEVICE

Sham Transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Admission criteria for patients with prolonged disorders of consciousness (Total 200) Inclusion Criteria:(1)Age 14-80 years;(2)In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;(3)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(4) right-handed；(5)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements;

Admission criteria for patients with acute disorders of consciousness(Total 300) Inclusion Criteria:（1)Age 14-60 years;（2）Meets diagnostic criteria for coma recognized in international studies；(3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(5) right-handed；(6)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;(5)No spontaneous breathing;(6)Status Epilepticus;(7)Need emergency neurosurgical treatment can not cooperate with the examination;

Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No