Individualized brain stimulation for patients with disorders of consciousness
Effect of Individualized Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Disorder of Consciousness
This study is testing if a special type of brain stimulation can help improve awareness and recovery in patients with severe brain injuries who are not fully conscious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05187000 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of individualized repetitive transcranial magnetic stimulation (rTMS) on patients diagnosed with disorders of consciousness (DOC) due to severe brain injuries. It employs a double-blind, randomized, sham-controlled crossover design involving 30 participants, who will receive a total of 20 sessions of either active or sham rTMS. The study aims to assess the potential of rTMS in promoting rehabilitation and improving consciousness in DOC patients, which is a challenging area of treatment. Participants will be monitored for their responses to the stimulation to determine the efficacy of this non-invasive technique.
Who should consider this trial
Good fit: Ideal candidates include individuals with acquired brain injuries resulting in disorders of consciousness, who have been stable for at least 28 days and less than one year.
Not a fit: Patients with uncontrolled epilepsy, recent seizures, or those involved in other neuroregulation trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance rehabilitation outcomes for patients with disorders of consciousness.
How similar studies have performed: Previous studies have shown promising results with rTMS in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Chengwei Xu, BSc
- Email: 943131151@qq.com
- Phone: +86 134 5045 7096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.