The aim of this study is to compare the effect of repetitive trans cranial magnetic stimulation (RTMS) and placebo on mild cognitive impairment (MCI). The study is a not blinded, cross over and self-controlled clinical trial. 16 people, including men and women from Firoozgar and Rasool hospitals, affiliated to Iran University of Medical Sciences, who complain of memory impairment will be recruited to the study. The inclusion criteria is mild cognitive impairment based on MMSE(MiniMental Status Examination) and MCA(Montreal Cognitive impairment) tests .Treatable causes of dementia will be excluded from the study . Patients will be divided into two groups .The first group will receive RTMS while second group will receive Placebo. After 8 weeks two groups will be assessed and crossed over. First group will receive placebo and second group will receive RTMS up to 8 weeks. MMSE & MCA will be performed and compared after each 8 weeks. This study will be performed in a five months
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011028199N2
Registration date:2017-04-27, 1396/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Ensieh Malekdar
Name of organization / entity
Iran Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 611 8572
Email address
mehrpour.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Repetetive Transcranial Magnetic Stimulation(RTMS) on Mild Cognitive Impairment (MCI)
Public title
Effect of Repetetive Transcranial Magnetic Stimulation(RTMS) on Mild Cognitive Impairment (MCI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
Patients with MCI(mild cognitive impairement) based on complaint of memory impairment with MMSE(mini mental status exam) score of more than 24 / 30 ؛ MCA(Montreal Cognitive Asessment)score of more than 26 / 30.
Exclusion criteria : Dementia confirmed with MMSE score of less than 24 /30؛ MCA score of less than 26 / 30 ؛Other treatable causes of dementia including serum B12 level below 200 Pg/ml ؛ hypothyroidism with thyroid stimulating hormone of above 6 uU/ml؛ any lesion on brain computed tomography scan explaining forgetfulness ؛ Depression rolled out in the recruited population with Beck screening test 14-28.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
We will use Closed Packet in both intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Postal code
1449614535
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.IUMS.REC.1394.9211158008
Health conditions studied
1
Description of health condition studied
Mild cognitive disorder
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Evaluation of change in cognitive function
Timepoint
From one week before intervention & placebo to one week after intervention & placebo
Method of measurement
Questionnaire includes Mini Mental Cognitive Exam and Montreal Cognitive Assessment
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1:
8 patients in this study will be treated with RTMS 2-3 times per week for 8 weeks with every session lasts for 30 minutes. Device for induction of magnitude wave is named Magnature which is made in Denmark .the frequency is above 1 Hz and usually above 10 Hz which has the optimal stimulation effect on postero-lateral prefrontal cortex.
Intensity:
The intensity is the minimum stimulation which is required to induce contraction of small hand muscles observed by a physician or recorded by an electromyogram. This intensity is usually 100 to 120 percent of resting membrane potential of a neuron.
Time of stimulation: 10 seconds.
Location of stimulation: left dorsolateral prefrontal cortex which is related to memory.
Interval of stimulations: 0.20 seconds.
Number of stimulation in every sessions: 1000
Time of every session: 30 minutes
Number of sessions: 2-3 sessions per week, up to 8 weeks.
The treated group are subsequently treated with placebo for the next 8 sessions via voice without magnitude after mentioned cognitive tests ( Mini-Mental State Exam & Montreal Cognitive Assessment) being performed
Cognitive tests will be performed for both groups at the end of the last session
Category
Treatment - Devices
2
Description
Intervention group 2:
8 patients will be initially treated with placebo for 8 weeks via pure voice without real magnitude wave cognitive tests. Cognitive tests will be performed at the end of the 8th week. The mentioned group will later be treated by real magnitude wave for 8 weeks and mentioned cognitive tests will be repeated
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Ensieh Malekdar, Neurology student, Iran University of Medical Science
Street address
Valadee street, Valiasr square, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Rasoole akram hospital
Full name of responsible person
Ensieh Malekdar,Neurology student, Iran university of Medical Science
Street address
Niaiesh street, Sattarkhan street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Iran University of Medical Science
Full name of responsible person
Doctor Masood Mehrpour
Street address
beside Milad hospital, Hemmat highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Ensieh Malekdar
Position
4th years resident in Neurology feild
Other areas of specialty/work
Street address
Valadi street, Valiasr square, Tehran
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1718
Fax
+98 21 8214 1321
Email
THEFIRSTMAJID@YAHOO.COM info@ent-hns.org
Web page address
firuzgar.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Dr.Masood Mehrpour
Position
Head of stroke center, Firoozgar Hospital, Associate professor,Neuronterventionist
Other areas of specialty/work
Street address
Valadi street, Valiasr square ,Tehran
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1718
Fax
+98 21 8214 1321
Email
mehrpour.m@iums.ac.ir
Web page address
www.firuzgar.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Dr.Masood Mehrpour
Position
Head of stroke center, Firoozgar Hospital, Associate professor,Neuronterventionist
Other areas of specialty/work
Street address
Valadi street, Valiasr square ,Tehran
City
Tehran
Postal code
1593748711
Phone
+98 21 8214 1718
Fax
+98 21 8214 1321
Email
mehrpour.m@iums.ac.ir
Web page address
www.firoozgar.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)