Disorders of Consciousness, Minimally Conscious State, Severe Brain Injury, Unresponsive Wakefulness Syndrome
Conditions
Brief summary
The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.
Interventions
DEVICEtTIS
CM-pf tTIS
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRS-R total score changes | From enrollment to the end of treatment at 10 days | Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of patients with improved consciousness | From enrollment to the end of treatment at 10 days | — |
| EEG changes | From enrollment to the end of treatment at 10 days | EEG power spectra, Connectivity and ABCD model, etc |
Countries
China
Contacts
Primary ContactGengyao Hu
Outcome results
None listed