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The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase

Protocol summary

Study aim
Effect of Transcranial direct-current stimulation (TDCS) in Recovery of Patients with Traumatic Brain Injury who had Insomnia
Design
A randomized double-blind clinical trial study of 64 patients with traumatic brain injury with subacute insomnia disorder who referred to Poursina Clinic and met the inclusion criteria of each group including 32 patients. 1- Get real tDCS 2- Get sham tDCS with medicine.
Settings and conduct
A randomized double-blind clinical trial study of 64 patients with traumatic brain injury with subacute insomnia disorder referred to Poursina Clinic. The intervener randomly selects the block and applies the assignment of the sample to the groups based on that block.
Participants/Inclusion and exclusion criteria
Inclusion: 18 to 65 years of age, brain scan findings, patency more than two weeks to one month after injury, ISI score up to 7 Exclusion: Sleep disorders, psychotropic medication one month before inclusion, neurological diseases, previous traumas, pregnant patients, pacemaker implants and psychoactive drugs, drug abuse,neurological diseases, history of seizures, tumor, neurotrauma, stroke,eczema of subdermal tDCS electrodes. Behavioral problems - Phenytoin, carbamazepine, verapamil, nimodepine and flunarzine, etc. - dissatisfaction
Intervention groups
2 intervention groups. Each group consisted of 32 subjects. 1-Get real tDCS 2-Get sham tDCS with medicine.
Main outcome variables
Insomnia severity index(ISI) Pittsburgh sleep quality index(PSQI)

General information

Reason for update
Acronym
tDCS-TBI
IRCT registration information
IRCT registration number: IRCT20130416013027N2
Registration date: 2019-12-23, 1398/10/02
Registration timing: registered_while_recruiting

Last update: 2019-12-23, 1398/10/02
Update count: 0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Sara Ramezani Kapourchali
Name of organization / entity
Guilan Road Trauma Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 8373
Email address
s.ramezanislp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-26, 1398/06/04
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase
Public title
The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during sub-acute phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 65 years Normal and abnormal findings on brain scans within the first 24 hours of hospitalization all TBI severity at least 2 weeks to one month after the time of injury onset The ISI score is over 7 .
Exclusion criteria:
People with a history of primary sleep disorders taking psychotropic drugs one month before entering the study having serious neurological and psychiatric disorders patients with previous traumas those with tDCS contraception, such as pregnant patients, patients with metal implants or pains, those having a heart pacemaker, taking a psychoactive drug or an effective CNS drug, substance abusers, existence of psychiatric and neurological diseases , a history of seizure, epilepsy, tumor, Neurotrauma, stroke, or neurological diseases, those experiencing skin eczema under the tDCS electrodes Clinical instability or having behavioral problems that prevent the cooperation of the subject in the intervention The use of sodium and calcium-dependent calcium channel blockers such as phenytoin, carbamazepine, verapamil, nimesadine, and flonarazine having a serious complication associated with tDCS The patient's dissatisfaction with the continuation of the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Samples by are divided into two intervention groups by sealed envelope software using random blocks method including Four blocks. Each group includes 32 people. 1- A group receiving true tDCS 2- A group that receives tDCS plus medicine. The intervener randomly chooses a block and applies the assignment of the sample to the groups based on that block.
Blinding (investigator's opinion)
Double blinded
Blinding description
During blinding, an individual other than the patient's examiner sets the device for triggering or not, so the examiner and the patient are not known to be in the tDCS group or the sham.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
namjoo ave-poursina hospital-way trauma research center
City
Rasht
Province
Guilan
Postal code
4193713194
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.GUMS.REC.1398.182

Health conditions studied

1

Description of health condition studied
Insomnia in subacute traumatic brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury

Primary outcomes

1

Description
The severity of insomnia disorder in patients with traumatic brain injury in subacute phase The score on the Insomnia Disorder Intensity Index (ISI) ranged from 0 to 28
Timepoint
Before starting study and one to three months after starting study
Method of measurement
ISI(Insomnia severty index)

2

Description
Sleep quality in patients with traumatic brain injury in subacute phase with a total score on the Pittsburgh Sleep Quality Index (PQQI) score between 0 and 21
Timepoint
Before starting study and one to three months after starting study
Method of measurement
PSQI(Pittsburg sleep quality index)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:32 patients. The group receiving the actual tDCS. Anodal tDCS is performed on the right DLPFC and cathodal on the left shoulder with a 1.5 mA excitation intensity and a 15-min excitation duration over 15 weekly sessions of 5 consecutive sessions for three weeks.
Category
Treatment - Devices

2

Description
Control group:Includes 32 patients receiving sham tDCS with medication. In the control group, 30 seconds of electrical stimulation is applied and then discontinued. But they receive drug treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurosurgery Clinic of Poursina Hospital
Full name of responsible person
Zohair Reihanian
Street address
Parastar Ave-Imam reza treatment clinic of Poursina Hospital
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 2444
Email
pedramesmaily@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shademan nemati
Street address
Namjoo Ave - Shahid Siadati Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
nemati@gums.ac.ir
Web page address
http://www.gums.ac.ir/research/default.aspx?tabid=10362
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Zohair Reihanian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Parastar Ave-PourSina Hospital-Trauma research center
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
+98 13 3331 1472
Email
zoheir.reihanian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Parastar Ave-PourSina Hospital-Trauma Research Center
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
+98 13 3331 1472
Email
s.ramezanislp@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Parastar Ave-PourSina Hospital-Trauma Research Center
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
+98 13 3331 1472
Email
s.ramezanislp@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some information related to main outcome are provided
When the data will become available and for how long
6 months after summary data published
To whom data/document is available
Only academic researchers
Under which criteria data/document could be used
For the therapeutic decision making in clinic
From where data/document is obtainable
s.ramezanislp@gmail.com
What processes are involved for a request to access data/document
Between 1 to 2 month after request
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