The purpose of this clinical trial is to investigate transcranial electrical stimulation on glioblastoma brain tumor growth and depression caused by it.
Design
A controlled, parallel-group, without blinding, randomized, clinical trial on 54 patients.Simple individual randomization with a sealed previously prepared envelope was used for randomization.
Settings and conduct
For the first intervention group, intermittent tECS is applied in the area where the glioblastoma brain tumor is located with a maximum current of 2 milliamps and a maximum voltage of 18 volts (during 20 consecutive sessions of 12 hours).
For the second intervention group, without applying electric current, it is performed with the same protocol.
All three treatment groups receive routine chemotherapy.
At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention), MRI images will be taken from all patients with the injection of Hamilton Depression Questionnaire and Beck Depression Questionnaire.
Location: National Brain Mapping Laboratory - Tarbiat Modares University - Loghman Hakim Hospital
Participants/Inclusion and exclusion criteria
Eligibility Criteria:
Patients aged between 10 years and 75 years
Patients with recurrent glioblastoma tumor
Exclusion criteria:
People with systemic diseases
Patient's non-cooperation
Intervention groups
18 patients simultaneously undergoing standard chemotherapy treatment
Another 18 patients are simultaneously treated with standard chemotherapy and alternating electric current
18 other patients are simultaneously treated with standard chemotherapy and alternating electric current of virtual feedback (without applying electrical stimulation).
Main outcome variables
Tumor size changes, depression amount changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045665N2
Registration date:2023-01-11, 1401/10/21
Registration timing:prospective
Last update:2023-01-11, 1401/10/21
Update count:0
Registration date
2023-01-11, 1401/10/21
Registrant information
Name
Mohammad Rostami
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3904
Email address
m-rostami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of transcranial electrical stimulation on GBM tumor growthand depression
Public title
The effect of transcranial electrical stimulation on brain tumor growth and depression caused by it trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 10-75 years old
Patients with recurrent Glioblastoma Brain tumor
Exclusion criteria:
People with systemic diseases
Patient's non-cooperation
Age
From 10 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with a sealed previously prepared envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Simulation Systems Laboratory, Faculty of Electrical Engineering, Tarbiat Modares University, Nasr Bridge, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2022-12-28, 1401/10/07
Ethics committee reference number
IR.IUMS.REC.1401.739
Health conditions studied
1
Description of health condition studied
Glioblastoma Brain Tumor
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain, unspecified
Primary outcomes
1
Description
Depression score in Hamilton questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention)
Method of measurement
Depression Hamilton Scale
2
Description
Tumor size in MRI with contrast
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention)
Method of measurement
MRI imaging
3
Description
Depression score in Beck questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention)
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current - ). Intermittent tECS is used where the glioblastoma brain tumor is located with a maximum current of 2 milliamps and a maximum voltage of 18 volts (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol.
Category
Treatment - Other
2
Description
Second intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current of virtual feedback - ). Intermittent tECS is used where the glioblastoma brain tumor is located without applying electrical stimulation (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol.
Category
Treatment - Other
3
Description
Control group: Simultaneously under standard chemotherapy treatment. They receive standard chemotherapy treatment according to the treatment protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Guive Sharifi
Street address
Special Street, Lashkar Crossroads, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Rostami
Street address
Simulator Systems Laboratory - Faculty of Electrical Engineering - Tarbiat Modares University- Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Fax
+98 912 359 3937
Email
M-Rostami@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mohammad Rostami
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Rostami
Position
Project manager of simulation systems laboratory of Tarbiat Modares University
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Simulator Systems Laboratory - Faculty of Electrical Engineering - Tarbiat Modares University- Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
M-Rostami@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Mohammad Rostami
Position
Project manager of simulation systems laboratory of Tarbiat Modares University
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Simulator Systems Laboratory - Nasr Bridge - Faculty of Electrical Engineering - Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
M-Rostami@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Mohammad Rostami
Position
Project manager of simulation systems laboratory of Tarbiat Modares University
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Simulator Systems Laboratory - Faculty of Electrical Engineering - Tarbiat Modares University - Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
M-Rostami@modares.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