Study of Effectiveness of Repetitive Transcranial Magnetic Stimulation(rTMS) on severity of Delirium.
Design
30 Delirious patients admitted to Rasoul-e-Akram Hospital, who were under psychiatric counseling, were randomly divided into two intervention and control groups
Settings and conduct
The site of the study is the Rasoul-e-Akram Hospital.The intervention group received a rTMS session, while the control group was treated with sham.Delirium severity is evaluated 15 minutes before and after magnetic stimulation evaluator and participants are not aware of intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria is Delirium diagnosis and being up to 18 years ;Exclusion Criteria is prohibited Cases of rTMS ,like Brain Tumor and Head Trauma .
Intervention groups
Intervention group,delirious patients that one session receive rTMS; Control group is treated with Sham with the same appearance of coil
Main outcome variables
Delirium Severity
General information
Reason for update
Acronym
rTMS Repetitive Transcranial Magnetic Stimulation
IRCT registration information
IRCT registration number:IRCT20171223038019N1
Registration date:2018-04-02, 1397/01/13
Registration timing:registered_while_recruiting
Last update:2018-04-02, 1397/01/13
Update count:0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Emad Yaghoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3663 3181
Email address
dr.emadyaghoubi@irimc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effectiveness of Repetitive Transcranial Magnetic Stimulation(rTMS) on severity of Delirium in Delirious Patients.
Public title
Effect of rTMS on severity of Delirium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Delirium Assessment with both Criteria CAM and DSM 5
Not Head Trauma in the one past year
Admit in non-psychiatric wards
Over 18 years old age
Informed Consent to participate in study
Exclusion criteria:
Doubt about Cerebrovascular accident
History of myocardial infarction, Heart valve surgery, Atrial fibrillation rhythm
Impaired cranial nerve examination
Asymmetry deep tendon reflex
Pupiledema
History of Dementia
Intubation patients
Opium or alcohol withdrawal syndrome
Metal piece or Pacemaker in body
Brain tumor
History of Seizure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization from permuted block randomization that the measure of blocks chosen randomly,allocation concealment by using of sequentially numbered ,sealed,opaque envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Project Participation and Delirium severity valuator are not informed of intervention and control groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Medical College, Near Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-11, 1396/07/19
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411286017
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium severity
Timepoint
15 minutes before intervention and 15 minutes after intervention
Method of measurement
NEECHAM Confusion Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive only one rTMS session, which is performed between 9 to 13 O'clock,Delirium severity is evaluated 15 minutes before and 15 minutes after intervention based on NEECHAM scale.Magnetic stimulation is performed in the left dorsolateral prefrontal cortex with a theta burst.burst pulse3.interpulse interval 20 millisecond frequency 5. The machine is made by magventure company and its model is Mag pro X100.
Category
Treatment - Devices
2
Description
Control group: As the intervention group, they receive a rTMS session, but instead of the active coil, they are treated with the sham that looks like coil.