comparison of the results of Glasscow outcom scale (GOSE) before and 2 weeks after zolpidem consumption
comparison of the quantitative and qualitative visual results of regional brain perfusion in Single-photon emission computed tomography (SPECT) before and 2 weeks after zolpidem consumption
Design
all vegetative patients for 4-8 months after TBI selected consequently from traumatic brain injury database. All patients will be assessed neurologically by a neurosurgeon according to GOSE scaling. Then, patients will be referred to nuclear medicine department for baseline brain perfusion SPECT scan with 99mTc-ECD. After SPECT, Zolpidem 10mg orally BID will be started. After 2 weeks, GOSE and brain perfusion SPECT will be repeated for evaluation of response to treatment 1 hour after oral administration of 10 mg zolpidem. The results of clinical and imaging data before and two weeks after administration of zolpidem will be recorded and analyzed statistically
Settings and conduct
vegetative patients selected consequently from traumatic brain injury database of shiraz trauma center (no blinding or randomization)
Participants/Inclusion and exclusion criteria
main inclusion criteria: being in vegetative state due to trauma for more than 4-8 months, in a medically stable condition
main exclusion: allergy to zolpidem
Evaluation of zolpidem effect on level of conciousness and regional brain perfusion in patients with vegetative state due to trauma
Public title
Zolpidem trial in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being in vegetative state due to trauma for more than 4-8 months, in a medically stable condition
no severe complications or other comorbidities in addition to brain damage
good nutritional status (BMI>18 kg/m2)
accepting to participate in the study by patients' family or guardian
Exclusion criteria:
Allergic reaction to zolpidem
Indication for any additional surgical or medical intervention during zolpidem treatment
poor cooperation for SPECT imaging
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
33
Actual sample size reached:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Approval date
2018-05-03, 1397/02/13
Ethics committee reference number
IR.SUMS.MED.REC.1397.080
Health conditions studied
1
Description of health condition studied
Vegetative life after traumatic brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
motor part of GCS
Timepoint
at biggining and two weeks later after treatment
Method of measurement
physical exam by physician
2
Description
glascow outcome scale extended (GOSE)
Timepoint
at biggining and two weeks later after treatment
Method of measurement
physical exam by physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Zolpidem 10 mg PO BID for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emtiaz hospital
Full name of responsible person
Hossein Ali Khalili
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
khalili_h@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
hosseinali khalili
Street address
Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
hosseinali khalili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emtiaz hospital, Chamran Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3625 4206
Email
khalili_h@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3624 8980
Fax
+98 71 3624 8980
Email
khalili_h@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hosseinali Khalili
Position
Associat professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Rajaee Hospital, Chamran Boulevard, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3624 8980
Fax
+98 71 3624 8980
Email
khalili_h@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available