This study is a three-blind randomized clinical trial that will be conducted in two treatment centers (Kashani and Al-Zahra) of Isfahan University of Medical Sciences. The studied population will be patients with severe brain trauma who refer to one of these two treatment centers and are hospitalized.
Settings and conduct
This study is a three-blind randomized clinical trial that will be conducted in two treatment centers (Kashani and Al-Zahra) of Isfahan University of Medical Sciences. The studied population will be patients with severe brain trauma who refer to one of these two treatment centers and are hospitalized. In fact, patients who have spasticity will be examined in the first six months after the trauma.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being between 18 and 65 years old More than a month has passed since the beginning of the trauma Having a level of consciousness less than 9 Not having a neurological or psychological disease before the trauma Presence of spasticity in the upper or lower limbs according to the Ashworth criteria.
Exclusion Criteria: Lack of consent of the patient's companion to enter the study Having a level of consciousness higher than 9 at the beginning of the trauma History of seizures, kidney and liver diseases
Intervention groups
Group 1: Dalfampridine receptor (this drug is prescribed to the patient at a dose of 10 mg twice a day (every 12 hours)) and will continue for 12 weeks.
Group 2: placebo recipient (this drug is prescribed to the patient twice a day)
Main outcome variables
Severity of spasms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N2
Registration date:2023-05-08, 1402/02/18
Registration timing:prospective
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of dalfampridine in improving spasticity in patients with severe brain trauma
Public title
Dalfampridine in improving spasticity in patients with severe brain trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 65 years old
More than a month has passed since the beginning of the trauma
Having a level of consciousness less than 9
Not having a neurological or psychological disease before the trauma
Presence of spasticity in the upper or lower limbs according to the Ashworth criteria
Exclusion criteria:
Lack of consent of the patient's companion to enter the study
Having a level of consciousness higher than 9 at the beginning of the trauma
History of seizures, kidney and liver diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
People are placed in 2 groups by random block method.
In this way, the first 2 eligible people are selected and after obtaining consent, they enter to participate in the study. These 2 people are considered as a block of 2 and are sorted according to the last digit of the national code. The treatment methods are specified as A, B, and all combinations of 2 are specified, and after the last surgery, decoding is done for the last block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-02-05, 1400/11/16
Ethics committee reference number
IR.MUI.MED.REC.1400.784
Health conditions studied
1
Description of health condition studied
Severe traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Severity of muscle spasms
Timepoint
Before treatment, three and six months after the intervention
Method of measurement
Ashworth scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dalfampridine receptor (this drug is prescribed to the patient at a dose of 10 mg twice a day (every 12 hours))
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mehdi Mahmoodkhani
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Fax
Email
kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Esfahan University of Medical Sciences
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
kashani street
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
mahmoodkhani@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Mahmoodkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
mahmoodkhani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Mahmoodkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
83434-81839
Phone
+98 31 3233 0091
Email
mahmoodkhani@med.mui.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