Brain Injuries Clinical Trial
Official title:
Effects of Repetitive Transcranial Magnetic Stimulation(rTMS) on Respiratory Function and Gut Microbiota in Patients With Brain Injury
Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process.
Status | Not yet recruiting |
Enrollment | 74 |
Est. completion date | December 31, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - In line with the diagnostic criteria of "Chinese classification of cerebrovascular diseases(2015)" mRS Score 2-4 points or craniocerebral injury caused by trauma, GCS score > 8 points - Between 18 and 70 years old - The first incidence of cerebrovascular disease or traumatic brain injury, and the course of disease was 10-180 days - Vital signs are stable, no progression - Voluntary participation with informed consent Exclusion Criteria: - Patients with a history of respiratory disease, including chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, and lung cancer - Severe bone malformations in the chest or spine - Have other neurological or neuromuscular disorders - History of thoracic and abdominal surgery - Severe heart, lung, kidney, liver or other organ dysfunction - Pregnant and lactating women - Epilepsy - Metal implant - Patients who were judged by the investigator to be unsuitable for participation in this trial |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital, Southern Medical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragm thickness | Diaphragm thickness was measured using a 10-15 MHz linear array probe, and the probe was positioned in the 8th to 11th costal space between the midaxillary line or anterior axillary line, perpendicular to the skin at the end of inspiratory phase and the end of expiratory phase. | Day 0,Week 4 | |
Primary | Thickening fraction | Thickening fraction = (end-inspiratory diaphragm thickness-end expiratory | Day 0,Week 4 | |
Secondary | Diaphragm mobility | Diaphragm mobility was measured with a 2-5MHz convex array probe, which was located below the costal arch of the midline of the clavicle. The above indexes were measured for 3 consecutive respiratory cycles and averaged. | Day 0,Week 4 | |
Secondary | Surface EMG of diaphragm | The latency period, amplitude and motion threshold were determined by Transcranial magnetic stimulation of motor evoked potential(TMS-MEP). | Day 0,Week 4 | |
Secondary | Forced vital capacity(FVC) | The FVC is measured using an Master-Screen spirometer | Day 0,Week 4 | |
Secondary | Forced expiratory volume at one second(FEV1) | The FEV1 is measured using an Master-Screen spirometer | Day 0,Week 4 | |
Secondary | Peak expiratory flow (PEF) | The PEF is measured using an Master-Screen spirometer | Day 0,Week 4 | |
Secondary | Maximum voluntary ventilation (MVV) | The MVV is measured using an Master-Screen spirometer | Day 0,Week 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03400904 -
Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.
|
||
Completed |
NCT06073145 -
Transcranial Doppler Using Wearable Ultrasound Patch
|
||
Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
Recruiting |
NCT06010823 -
Safety and Efficacy Evaluation of the Robotic Enhanced Error Training of Upper Limb Function in Post-stroke and Post TBI Participants
|
N/A | |
Not yet recruiting |
NCT05833568 -
Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness
|
N/A | |
Withdrawn |
NCT04288076 -
The Brain and Lung Interaction (BALI) Study
|
N/A | |
Not yet recruiting |
NCT02756585 -
Computed Tomography Perfusion in Patients With Severe Head Injury
|
N/A | |
Completed |
NCT03162484 -
Physical Activity and Chronic Acquired Brain Injury
|
N/A | |
Terminated |
NCT01430988 -
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|
N/A | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A | |
Completed |
NCT00975338 -
The LETS Study: A Longitudinal Evaluation of Transition Services
|
||
Completed |
NCT00878631 -
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
|
Phase 2/Phase 3 | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Not yet recruiting |
NCT04478812 -
Tbit System Precision and Correlation of Different Blood Samples
|
N/A | |
Recruiting |
NCT05309005 -
Virtual Reality and Social Cognition After Acquired Brain Injury
|
||
Recruiting |
NCT05443542 -
VIrtual Reality in Cognitive Rehabilitation of Processing Speed for Persons With ABI
|
N/A | |
Completed |
NCT02702635 -
Measuring Blood Flow Characteristics Using Dynamic Contrast Enhanced Magnetic Resonance Imaging
|
N/A | |
Withdrawn |
NCT04247321 -
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
|
N/A | |
Not yet recruiting |
NCT04386525 -
Omega 3 and Ischemic Stroke; Fish Oil as an Option
|
Phase 4 |