Effects of Individualized rTMS in DOC Patients

Launched by QIUYOU XIE · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called repetitive transcranial magnetic stimulation (rTMS) on patients with a Disorder of Consciousness (DOC). DOC can occur after severe brain injuries, making it hard for patients to respond or interact with their surroundings. The goal of the study is to see if rTMS, a non-invasive technique that stimulates the brain, can help improve the awareness and responsiveness of these patients.

To participate, patients must be diagnosed with DOC due to a brain injury that happened less than a year ago and have been in this state for at least 28 days. They should not have a history of certain psychiatric conditions or any medical devices that could interfere with the treatment. In the trial, 30 participants will receive a total of 20 sessions, alternating between active rTMS and a placebo treatment that looks the same but has no effect. Throughout the study, researchers will assess the patients' responses to the treatment and gather important brain activity data to better understand how rTMS works. This trial is currently recruiting participants, and family members must provide consent for their loved ones to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. acquired brain injuries less than 1 year and more than 28 days in DOC;
• • 2. clinical diagnosis of DOC Disease;
• • 3. no medical history of neuropsychiatric diseases;
• • 4. no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;
• • 5. stable state of disease and vital signs;
• • 6. the families of the patients volunteered the patient to participate in the study and provided signed informed consent;
• • 7. the integrity of the individualized stimulation target cortex are verified by MRI.
• Exclusion Criteria:
• • 1. patients in other non-invasive or invasive neuroregulation trials;
• • 2. motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
• • 3. uncontrolled epilepsy, seizure within 4 weeks before enrollment;
• • 4. metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.