Dec. 23, 2020 |
|
Feb. 13, 2024 |
|
jRCTs032200263 |
Confirmation of safety for patients with traumatic brain injury by transcranial direct current stimulation (TDCSTBI) |
|
tDCS study for TBI (TDCSTBI) |
Higuchi Yoshinori |
||
Chiba University Hospital |
||
1-8-1 Inohana, Chuo-ku, Chiba city |
||
+81-43-226-2158 |
||
yhiguchi@faculty.chiba-u.jp |
||
Higuchi Yoshinori |
||
Chiba University Hospital |
||
1-8-1 Inohana, Chuo-ku, Chiba city |
||
+81-43-226-2158 |
||
yhiguchi@faculty.chiba-u.jp |
Recruiting |
Dec. 23, 2020 |
||
6 | ||
Interventional |
||
single arm study |
||
open(masking not used) |
||
uncontrolled control |
||
single assignment |
||
treatment purpose |
||
1) Patients with a diagnosis of severe brain injury of 8 or less on the Glasgow Coma Scale (GCS) and requiring hospitalization follwoing 1-2 months after the injury. |
||
1) Patients who are unable to remain at rest |
||
16age old over | ||
80age old under | ||
Both |
||
Severe traumatic brain injury |
||
transcranial direct current stimulation |
||
traumatic brain injury, subdural hematoma, diffuse brain injury |
||
transcranial direct current stimulation |
||
D000070642, D006408, D000070625 |
||
D004599 |
||
Proportion of the following severe adverse events associated with the study device that occurred within the period of constant stimulation treatment will be evaluated. (number of patients occurring/number of patients) |
||
Neurological score (GCS, CRS-R) |
Rehabilitation Center for Traumatic Apallics Chiba, National Agency for Automotive Safety and Victim | |
Applicable |
Chiba University Certified Clinical Research Review Board | |
Inohana 1-8-1, Chuo-ku, Chiba city, Chiba | |
+81-43-226-2616 |
|
prc-jim@chiba-u.jp | |
Approval | |
Sept. 30, 2020 |
No |
|
none |