Effect of brain stimulation on consciousness in patients with disorders of consciousness
To Explore the Intervention Effect of High Definition-transcranial Alternating Current Stimulation (HD-tACS) on Consciousness Promotion in Patients With Chronic Consciousness Disorders and the Potential Neural Mechanism
This study is testing if a special type of brain stimulation can help improve awareness in people who have chronic disorders of consciousness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06076733 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of high definition-transcranial alternating current stimulation (HD-tACS) on promoting consciousness in patients with chronic disorders of consciousness. Forty participants will be randomly assigned to receive either active or sham stimulation, with the active treatment involving a specific electrode placement and stimulation protocol over ten days. The effectiveness of the intervention will be assessed using the coma recovery scale-revised (CRS-R) and EEG data will be collected to explore the underlying neural mechanisms. The goal is to determine if this non-invasive stimulation can enhance consciousness in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with chronic disorders of consciousness who have not shown improvement in consciousness for at least one week.
Not a fit: Patients with severe neurocognitive degenerative diseases, metal implants in the head, or a history of epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved consciousness and quality of life for patients with chronic disorders of consciousness.
How similar studies have performed: While the approach of using tACS is gaining interest, the specific application for disorders of consciousness is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients diagnosed as chronic disorders of consciousness based on CRS-R assessment by at least two professional neurologists; 2. the age requirement is between 18 and 75; 3. vital signs need to be stable; 4. no neuromuscular blockers and sedatives have been used within 24 hours before the study and the entire protocol; 5. no improvement in the state of consciousness was observed within one week before the start of the study. Exclusion Criteria: 1. previous or current diagnosis of severe neurocognitive degenerative diseases; 2. metal implantation in the head; 3. previous surgical procedures resulted in skull defect; 4. previous history of epilepsy.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Kai Wang, PhD — Director of medical psychological department, Anhui Medical University
- Study coordinator: Kai Wang, PhD
- Email: wangkai1964@126.com
- Phone: +86-0551-62923704
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.