Evaluation of the effectiveness of TDCS (Transcranial Direct Current Stimulation) in the treatment of prolonged anosmia and hyposmia in patients with Covid-19
Design
Clinical trial without control group as a case seris study on 10 patients.
Settings and conduct
Patients in the physical medicine ward of Hazrat Rasool Akram Hospital undergo four sessions of TDCS(Transcranial Direct Current Stimulation). Patients' sense of smell is measured by SIT (Smell Identification) Test before the intervention and one week after four TDCS sessions.
Participants/Inclusion and exclusion criteria
Age between 18 and 60 years
Loss of sense of smell after Covid-19 (anosmia or hyposmia that has not improved for more than a month after the onset of symptoms and with routine treatment)
Exclusion criteria also include cases in which the use of the TDCS method is contraindicated:
1. Pregnancy 2. History of chronic pain tolerance conditions 3. Seizures or family history of seizures 3. Implanted metal devices such as pacemakers, metal plate and wire 4. History of brain surgery
Intervention groups
Ten patients who develop a prolonged diminished or loss of sense of smell after Covid 19 disease receive four sessions of TDCS treatment. Patients' sense of smell is measured before the intervention and one week after the intervention, using the SIT test.
Main outcome variables
Olfactory sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038619N2
Registration date:2021-08-30, 1400/06/08
Registration timing:prospective
Last update:2021-08-30, 1400/06/08
Update count:0
Registration date
2021-08-30, 1400/06/08
Registrant information
Name
Katayoun Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6574
Email address
katayounmoradi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-10, 1400/06/19
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of TDCS (Transcranial Direct Current Stimulation) in the treatment of hyposmia in patients with Covid-19
Public title
Evaluation of the effectiveness of TDCS (Transcranial Direct Current Stimulation) in the treatment of prolonged decreased of sense of smell in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
Loss of sense of smell after Covid-19 (anosmia that has not improved for more than a month after the onset of symptoms and with routine treatment)
Decreased of sense of smell after Covid-19 (anosmia that has not improved for more than a month after the onset of symptoms and with routine treatment)
Exclusion criteria:
Pregnancy
Seizures or family history of seizures
Implanted metal devices such as pacemakers, metal plate and wire
History of brain surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Ethics committee, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.IUMS.REC.1399.1089
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Olfactory sensitivity
Timepoint
Patients are assessed before the intervention and one week after 4 sessions of TDCS.
Method of measurement
Participants' olfactory sensitivity will be measured by the Smell Identification Test (SIT) . In this method, 24 Iranianized odor such as rose, caffeine, saffron, etc. will be used and a score of 24 will be given, with a score of 19 to 24 being considered the normal range. A score of 14 to 18 is mild microsmia, a score of 10 to 13 is severe microsmia, and a score of 0 to 9 is anosmia.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive a direct current of 2 mA for 20 minutes. In all patients, the anode electrode is located on the left DLPFC region and the cathode electrode is located on the right DLPFC region. The excitation current will be generated by a direct current generator with a maximum current of 4 mA (NeuroStim2 dual channel device). To transmit current, a 35 cm square electrode covered with 0.9% saline-impregnated sponge will be used.