IRCT | Evaluating the effect of transcranial direct current stimulation, olfactory stimulation and their combination in intensive care unit (ICU) patients with disorder of consciousness (DOC)

Protocol summary

Study aim: Evaluation of the effect of transcranial direct current stimulation, olfactory stimulation and their combination in intensive care unit (ICU) patients with disorder of consciousness (DOC)
Design: A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 60 patients. A computer randomization sequence was used for randomization.
Settings and conduct: This study is conducted as a clinical trial on the patients of the intensive care unit with disorder of consciousness referred to Loghman Hakim Hospital. Patients who meet the inclusion criteria are randomly assigned to one of three groups. The data will be coded and without the patient's name and grouping, and in sealed envelopes, will be provided to the person analyzing the data.The patient and the person evaluating the data are blind.
Participants/Inclusion and exclusion criteria: Inclusion criteria included age ≥ 18 years, brain injuries, non-hemorrhagic stroke, Glasgow Coma Scale greater than 9, 7. Patients without tracheostomy, and exclusion criteria included complications reducing brain function, referral to other centers, and patient death.
Intervention groups: In the transcranial direct current stimulation (tDCS) group, participants will receive tDCS daily for five consecutive days in 20-minute sessions targeting areas of the brain involved in consciousness, such as the left dorsolateral prefrontal cortex (DLPFC).In the olfactory stimulation group, the participants are subjected to olfactory stimulation for 15 minutes, twice a day, for a period of five days, using unpleasant scents and the stimulant pyridine. In the combination group, participants will receive both tDCS and olfactory stimulation.
Main outcome variables: Glasgow Coma Scale; quantitative electroencephalography; length of stay in ICU; Complications of hospitalization in ICU; Prognosis, tDCS stimulation; olfactory stimulation

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240608062040N1

Registration date: 2024-06-21, 1403/04/01

Registration timing: prospective

Last update: 2024-06-21, 1403/04/01

Update count: 0
Registration date: 2024-06-21, 1403/04/01

Registrant information: Name

Ali Vafaei

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 8869 2109

Email address

avafaei.dr@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-07-22, 1403/05/01
Expected recruitment end date: 2024-12-21, 1403/10/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluating the effect of transcranial direct current stimulation, olfactory stimulation and their combination in intensive care unit (ICU) patients with disorder of consciousness (DOC)

Public title: The effect of transcranial direct current stimulation and olfactory stimulation in intensive care unit (ICU) patients with disorder of consciousness (DOC)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age above 18 years People with brain damage Non-hemorrhagic cerebrovascular accident (CVA) Glasgow Coma Scale (GCS) greater than 9 No administration of neuromuscular system blockers or sedatives within 24 hours after entering the study Diagnosis of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS), based on repeated behavioral assessments using the Coma Recovery Scale-Revised (CRS-R) (ie, at least five assessments per week) Patients without tracheostomy Patients without intracerebral hemorrhage (ICH) Patients without subarachnoid hemorrhage (SAH) Patients without intubation Patients without previous history of neurological or psychiatric disease Patients who did not use neuromuscular blocking drugs or sedative drugs in the 24 hours before the test. Patients with no documented history of previous coma, critical illness, or unstable medical condition Patients with no history of seizures

Exclusion criteria:

The patient suffers from a complication that reduces brain function
Age: From 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Participants will be randomly assigned to one of the three intervention groups using a computerized randomization sequence conducted by an independent investigator not involved in the study. Randomization after homogenization of the groups is done based on the confounding variable i.e. age and is classified based on the severity of the disorder according to the basic GCS scores to ensure a balanced distribution of the participants among the intervention groups.

Blinding (investigator's opinion)

Double blinded

Blinding description

Outcome assessments, including clinical assessments and quantitative electroencephalography (QEEG) measurements, will be performed by blind assessors who are unaware of the participants' assigned interventions. Patients have a reduced level of consciousness. There is also a group of patients who receive the sham TDCS protocol and the patients do not know which group they are in. Also, the person doing the electrical stimulation and the person doing the clinical assessment are different people.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee in biomedical research of Shahid Beheshti medical school

Street address

Yemen St, Shahid Chamran Highway

City

Tehran

Province

Tehran

Postal code

1983969411
Approval date: 2024-05-21, 1403/03/01
Ethics committee reference number: IR.SBMU.MSP.REC.1403.153

Health conditions studied

1

Description of health condition studied: Disorder of consciousness
ICD-10 code: R41.82
ICD-10 code description: Altered mental status, unspecified

Primary outcomes

1

Description: ICU coma scores
Timepoint: Daily during intervention stages
Method of measurement: Glasgow coma scale

2

Description: Quantitative electroencephalography(QEEG)
Timepoint: At the beginning of the intervention, immediately after the intervention and at the follow-up times (weekly and after 4 weeks of the intervention)
Method of measurement: QEEG brain mapping test

Secondary outcomes

1

Description: Safety monitoring of patients
Timepoint: Every week for four weeks after the intervention
Method of measurement: Side effects and potential side effects related to tDCS and olfactory stimulation will be carefully monitored using the Coma Recovery Scale-revised(CRS-R) during the study.

Intervention groups

1

Description: Intervention group: In the tDCS group, participants received transcranial direct current stimulation in brain regions involved in consciousness, such as the left dorsolateral prefrontal cortex, daily for five consecutive days and 20 minutes.
Category: Treatment - Other

2

Description: Intervention group: In the olfactory stimulation group, participants will receive olfactory stimulation using unpleasant and stimulating odors, pyridine. Participants in this group will receive olfactory stimulation using pyridine for 15 minutes twice a day over the same five-day period.
Category: Treatment - Other

3

Description: Control group: In the combination group, participants will receive both tDCS and olfactory stimulation.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Loghman Hakim Hospital

Full name of responsible person

Ali Vafaei

Street address

Lashgar Crossroads, South Kargar Street

City

Tehran

Province

Tehran

Postal code

1333635445

Phone

+98 21 5541 9009

Email

avafaei.dr@gmail.com

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Afshin Zarghi

Street address

Yemen St, Shahid Chamran Highway

City

Tehran

Province

Tehran

Postal code

1983969411

Phone

+98 21 8820 0096

Email

zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti 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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Ali Vafaei

Position

Sub specialist

Latest degree

Specialist

Other areas of specialty/work

Anesthesiology

Street address

Lashgar Crossroads, South Kargar Street, Loghman Hakim Hospital

City

Tehran

Province

Tehran

Postal code

1333635445

Phone

+98 21 5541 9005

Email

avafaei.dr@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Masood Zangi

Position

Assistant professor

Latest degree

Subspecialist

Other areas of specialty/work

Anesthesiology

Street address

Lashgar Crossroads, South Kargar Street, Loghman Hakim Hospital

City

Tehran

Province

Tehran

Postal code

1333635445

Phone

+98 21 5541 9009

Email

masood_zangi@sbmu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Mahdi Amirdosara

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Anesthesiology

Street address

Lashgar Crossroads, South Kargar Street, Loghman Hakim Hospital

City

Tehran

Province

Tehran

Postal code

1333635445

Phone

+98 21 5541 9009

Email

dr.amirdosara@gmail.com

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

Evaluating the effect of transcranial direct current stimulation, olfactory stimulation and their combination in intensive care unit (ICU) patients with disorder of consciousness (DOC)