UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018797 |
|---|---|
| Receipt number | R000021581 |
| Scientific Title | Acupuncture treatment for patients with chronic disorder of consciousness and severe cognitive disorder (higher brain dysfunction) following traffic traumatic brain injury |
| Date of disclosure of the study information | 2015/08/26 |
| Last modified on | 2015/08/25 15:51:07 |
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Basic information
Public title
Acupuncture treatment for patients with chronic disorder of consciousness and severe cognitive disorder (higher brain dysfunction) following traffic traumatic brain injury
Acronym
Acupuncture treatment for patients with severe traumatic brain injury
Scientific Title
Acupuncture treatment for patients with chronic disorder of consciousness and severe cognitive disorder (higher brain dysfunction) following traffic traumatic brain injury
Scientific Title:Acronym
Acupuncture treatment for patients with severe traumatic brain injury
Region
| Japan |
Condition
Condition
Chronic disorder of consciousness or severe cognitive disorder (higher brain dysfunction) following traumatic brain injury
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of acupuncture treatment for patients with chronic disorder of consciousness or severe cognitive disorder (higher brain dysfunction) following traumatic brain injury caused by traffic accidents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coma Recovery Scale, NASVA score
(Before and after treatment period)
Motor evoked potential using transcranial magnetic stimulation
Evoked electromyography (F wave, H reflex)
(Comparison of changes in variables in treatment and no treatment)
Key secondary outcomes
Range of motion, Modified Ashworth Scale
Electroencephalogram
Heart Rate Variability
Records of changes in the clinical symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupuncture (2 session per week, 4 months,1 or 2 course)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic disorder of consciousness following traumatic brain injury or higher brain dysfunction (severe cognitive disorder), who admitted in Chubu Medical Center for Prolonged Traumatic Brain Dysfunction.
At least three months after injury.
Key exclusion criteria
Subjects who are not stable in general condition.
Subjects whose treatments such as medications are changed within one month.
Subjects who can't keep the resting position during treatment or measurements.
Ineligibility for the study based on the decision of an investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Asano |
Organization
Chubu Medical Center for Prolonged Traumatic Brain dysfunction, Kizawa Memorial Hospital
Division name
Department of Nuerosurgery
Zip code
Address
630, Shimo-kobi, Kobi-cho, Minokamo, Gifu, Japan
TEL
0574-24-2233
y-asano@wind.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Asano |
Organization
Chubu Medical Center for Prolonged Traumatic Brain dysfunction, Kizawa Memorial Hospital
Division name
Department of Neurosurgery
Zip code
Address
630, Shimo-kobi, Kobi-cho, Minokamo, Gifu, Japan
TEL
0574-24-2233
Homepage URL
y-asano@wind.ocn.ne.jp
Sponsor or person
Institute
Chubu Medical Center for Prolonged Traumatic Brain dysfunction, Kizawa Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Chubu Medical Center for Prolonged Traumatic Brain dysfunction, Kizawa Memorial Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2015 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021581
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
