|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-IOR-16010091 |
|
Date of registration:
|
2016-12-05 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Magnetic resonance imaging study of hyperbaric oxygen treatment on cognitive dysfunction after traumatic brain injury
|
|
Scientific title:
|
Magnetic resonance imaging study of hyperbaric oxygen treatment on cognitive dysfunction after traumatic brain injury |
|
Date of first enrolment:
|
2015-04-01 |
|
Target sample size:
|
HBO:47;Sham:47; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=16107 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Peng Huiping
|
|
Address:
|
156 North Second Ring Road, Fuzhou, Fujian, China
350025
|
|
Telephone:
|
+86 13600823060 |
|
Email:
|
361140072@qq.com |
|
Affiliation:
|
Department of Rehabilitation Medicine, Fuzhou General Hospital of Nanjing Military Command, PLA. Fuzhou, Fujian |
|
|
Name:
|
Liu Yang
|
|
Address:
|
156 North Second Ring Road, Fuzhou, Fujian, China
350025
|
|
Telephone:
|
+86 18059714981 |
|
Email:
|
1003664277@qq.com |
|
Affiliation:
|
Department of Rehabilitation Medicine, Fuzhou General Hospital of Nanjing Military Command, PLA. Fuzhou, Fujian |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Be diagnosed with traumatic brain injury by CT or(and) MRI;
2. MMSE=26;
3. Aged 18 to 55 years;
4. During the post-injury recovery stage, lasting less than six mouths;
5. First brain injury;
6. BDI<14;
7. Information consent, participate the trial voluntary.
Exclusion criteria: 1. previous disease history: brain trauma, surgery, cerebral tumor or other brain lesions;
2. Serious words, vision, hearing impairment or mental disorders;
3. Past cognitive disorder or drug influenced on cognition;
4. MRI contraindications (non-removable denture, cardiac pacemaker, electronic cochlear implants, claustrophobia);
5. A history of drug abuse, alcohol;
6. patients with epilepsy; patients with severe heart, liver, or renal dysfunction; and patients with blood disorders;
7. Pregnancy or breast-feeding women;
8. For other clinical subjects.
Age minimum:
18
Age maximum:
55
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Traumatic brain injury
|
|
Intervention(s)
|
|
HBO:hyperbaric oxygen,conventional surgery and rehabilitation;Sham:Conventional surgery and rehabilitation;
|
|
Secondary Outcome(s)
|
|
cognitive function;fMRI;
|
|
Source(s) of Monetary Support
|
|
The foundation of innovation team of Fuzhou General Hospital of Nanjing Military ;Project on the surface of Fujian Province
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|