Noninvasive brain stimulation for patients with severe brain injuries and consciousness disorders
An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
This study tests if a new type of brain stimulation can help improve awareness and thinking in patients with severe brain injuries who are not fully conscious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 2 sites (Xi'an, Shaanxi and 1 other locations) |
| Trial ID | NCT06851156 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial temporal interference stimulation (tTIS) on patients suffering from disorders of consciousness, including unresponsive wakefulness syndrome and minimally conscious state. The approach involves noninvasive neuromodulation targeting specific brain regions to potentially enhance consciousness and cognitive function. The study aims to determine the efficacy of this innovative treatment in improving patient outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals with disorders of consciousness due to traumatic or nontraumatic brain injuries who meet specific diagnostic criteria.
Not a fit: Patients in a coma, those with less than one week post-acute brain injury, or those with certain medical devices or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the level of consciousness and quality of life for patients with severe brain injuries.
How similar studies have performed: While the approach of using tTIS is relatively novel, similar neuromodulation techniques have shown promise in other studies targeting consciousness disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria. Exclusion Criteria: * patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.
Where this trial is running
Xi'an, Shaanxi and 1 other locations
- Xijing Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: wen Jiang, phD — Xijing Hospital
- Study coordinator: Gengyao Hu
- Email: 304517021@qq.com
- Phone: 86-15399059833
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.