Effects of Transcranial direct-current stimulation (tDCS) on the treatment of depressive and anxiety symptoms and improve quality of sleep in patients with chronic renal diseases on dialysis- a randomized double-blind placebo controlled trial
Comorbidity of psychiatric disorders and end stage renal diseases (ESRD) which need special medication regimen, is a major challenge in front of nephrologists and psychiatrists. The main question of this study is whether the use of tDCS intervention – as a non-pharmacological treatment of mental disorders – can be effective on anxiety disorders, depression and sleep problems in chronic renal patients on dialysis. Subjects of two "anxiety-depression" and "sleep disorders" groups were selected from undergone hemodialysis patients with ESRD who referred to Fatemeh Zahra and Imam Khomeini hospitals of Sari, Mazandaran, Iran. Hospital Anxiety and Depression Scale (HADS) and Pittsburgh Sleep Quality Index (PSQI) questionnaire were used for each patient. tDCS intervention was performed according to protocol for 15 sessions. In addition to the pre-test, post-test at the end of 15 sessions, another test was also carried out after 10 days to follow-up the intervention effects. Results shows that even there has been a little reduction in scores of patients with symptoms of depression and anxiety after tDCS in compare to before that, but this reduction wasn't significant, so tDCS had no significant effect on improving symptoms of depression and anxiety. But the results of sleep disorder group, shows that there is a significant difference between the average scores of experimental group in three periods (before, after 15 sessions and 10 days after the end of intervention). Thus, it can be said that tDCS intervention has had positive effects on improving sleep quality
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020311885N8
Registration date:2017-04-01, 1396/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-01, 1396/01/12
Registrant information
Name
Samaneh Farnia
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
sfarnia@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Research Center of Psychiatry and Behavioral Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Transcranial direct-current stimulation (tDCS) on the treatment of depressive and anxiety symptoms and improve quality of sleep in patients with chronic renal diseases on dialysis- a randomized double-blind placebo controlled trial
Public title
Effects of Transcranial direct currency stimulation (tDCS) on the treatment of depressive and anxiety symptoms and improve quality of sleep in patients with chronic renal diseases on dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
History of head trauma in patient; history of epilepsy in patients or their families; past history of bipolar dx. or psychotic dx.; acute suicidal ideas; consumption of neuroleptics during the study; addiction to drugs or alcohol; pregnancy; having metal prosthesis or implant; severe anorexia; past history of neurologic dx. , serious medical illness.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences Ethics Committee
Street address
Mazandaran University of Medical Sciences, Moallem square
City
Sari
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MAZUMS.REC.95.1819
Health conditions studied
1
Description of health condition studied
Chronic renal diseases
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Anxiety, depression
Timepoint
Before intervention, after 15 sessions of intervention and 10 days after the end of inervention
Method of measurement
HADS questionnaire
2
Description
Sleep quality
Timepoint
Before intervention, after 15 sessions of intervention and 10 days after the end of inervention
Method of measurement
PSQI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In main intervention, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 20 minutes and then, the device automatically shuts down.
Category
Treatment - Devices
2
Description
in placebo group, Subject of two "anxiety and depression" and "sleep disorders" groups were under tDCS.F3-Fp2 protocol was used in main intervention group according to 10-20 system of regions of the brain, the area (F3) Dorsolateral Prefrontal Cortex (DLPFC) was stimulated with anode and contralateral supraorbital (Fp2) under cathodic inhibition. The stimulation started in ascending mode up to 2 mA, and with the enhanced of 2 mA continues for 30 seconds and then, the device automatically shuts down
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomini hospital
Full name of responsible person
Street address
City
sari
2
Recruitment center
Name of recruitment center
Fatemeh zahra hospital
Full name of responsible person
Street address
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology,Mazandaran university of medical sciences
Full name of responsible person
Maryam Javadian
Street address
Imam Squar, serah-e- jooybar, Valiasr Highway
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology,Mazandaran university of medical sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Samaneh Farnia
Position
Assistant professor
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences
City
Sari
Postal code
Phone
+98 11 3326 2646
Fax
Email
sfarnia@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Aalishah
Position
MD
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Dokhaniat street
City
Sari
Postal code
48139-66944
Phone
+98 11 3323 3757
Fax
Email
aliaalishah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Aalishah
Position
Resident
Other areas of specialty/work
Street address
Mazandaran university of medical science
City
Sari
Postal code
Phone
+98 11 3323 3757
Fax
Email
aliaalishah@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)