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Comparison of the effect of transcranial direct current stimulation (tDCS) and high definition stimulation (HD-tDCS) on cognitive-psychological symptoms in adults with restless leg syndrome (RLS)

Protocol summary

Study aim
The present study seeks to investigate transcranial direct-current stimulation (tDCS) and compare it with High definition- tDCS (HD-tDCS) to evaluate their effect on symptoms of restless legs syndrome.
Design
This is a clinical trial research include pre-test, post-test, one-month follow-up and control group. There are parallel groups of 45 subjects which randomly divide into three groups (two experimental and one control group).
Settings and conduct
This is a randomized clinical trial study in which the double blind method will be used. Therefore we refer to consulting Centers of Yazd and by using the convenience sampling method, people with discomfort and complaints of restless legs syndrome are suggested to participate in the study. We offer neurotherapy to satisfy the clients to participate in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of the disorder by a psychiatrist, Rejecting differential diagnosis by a neurologist, Aged between 18 to 75 years, Not suffering from cardiovascular disease and diabetes, Not Smoking, Non-pregnancy. Exclusion criteria: Dissatisfaction to participate in the research, Having a type of motor or cognitive disabilities, Receiving simultaneous psychiatric treatment, History of seizure disorders, Having a pacemaker
Intervention groups
The first intervention group received transcranial direct-current stimulation (tDCS) at 4 mA (positive stimulation) over 10 consecutive sessions. The second intervention group received High definition-tDCS (HD-tDCS) at 2 mA (positive stimulation) over 10 consecutive sessions. Ten sessions of HD-tDCS without electricity flow (sham mode) will be used for the control group.
Main outcome variables
Cognitive Symptoms, Depression, Severity of restless legs syndrome.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190708044138N1
Registration date: 2020-05-07, 1399/02/18
Registration timing: retrospective

Last update: 2020-05-07, 1399/02/18
Update count: 0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Mohammad Hossein Sorbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 1306
Email address
sorbih@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of transcranial direct current stimulation (tDCS) and high definition stimulation (HD-tDCS) on cognitive-psychological symptoms in adults with restless leg syndrome (RLS)
Public title
Effect of transcranial direct current stimulation and high definition stimulation on restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of restless legs syndrome by a psychiatrist or psychologist Gaining moderate to high score in severity of the syndrome (scores of 5 to 12) in the international restless legs syndrome questionnaire Rejecting differential diagnosis of neuro-motor disorder by a neurologist and absence of neurological disorder Aged between 18 to 75 years Not suffering from cardiovascular disease, kidney disease and diabetes (getting information by asking from participants and get help from a physician) Not Smoking and not taking painkillers, sedatives and hypnotics Non-pregnancy in women
Exclusion criteria:
Dissatisfaction to participate in the research Having a type of motor or cognitive disabilities that interferes working with computer Receiving simultaneous psychiatric treatment or other psychotherapies to relieve RLS symptoms History of seizure disorders in individuals, having a pacemaker, having a metal object in the head and neck or any other obstacle to do electrical stimulation
Age
From 18 years old to 75 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another independent researcher will measure the patients outcome and she will not know the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The neuroscientist of Yazd Psychological Center will be aware of the research topic and will perform therapeutic interventions. He codes the patients and refers them to a psychologist to check the patient's mental state and record the relevant criteria based on the same code. The patients will be tested in the same condition in the neurotherapy room and the electrodes of the device will be connected to them, but they will not be aware of the real or sham stimulation. Accordingly, this study will be a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Administration, Bahonar Sq., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.SSU.REC.1398.051

Health conditions studied

1

Description of health condition studied
restless legs syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
Cognitive Symptoms
Timepoint
Cognitive Symptoms was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session.
Method of measurement
The Integrated Visual and Auditory (IVA-2)

2

Description
Depression
Timepoint
Depression was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session.
Method of measurement
beck depression inventory (BDI-II)

3

Description
Severity of Restless Legs Syndrome
Timepoint
Severity of Restless Legs Syndrome was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session.
Method of measurement
International Restless Legs Syndrome Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group received transcranial direct current stimulation (HD-tDCS) at 4 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session).
Category
Treatment - Devices

2

Description
The second intervention group received high definition-transcranial direct current stimulation (HD-tDCS) at 2 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session).
Category
Treatment - Devices

3

Description
The first control group received high definition-transcranial direct current stimulation (HD-tDCS) with Sham over 10 consecutive sessions.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling Center and Psychological Services of Imam Hossein
Full name of responsible person
Dr. Hamid Mirhosseini
Street address
Imam Hussein Square, Yazd
City
Yazd
Province
Yazd
Postal code
8919973863
Phone
+98 35 3724 0049
Email
mirhoseini.h@gmail.com
Web page address
http://cps.yazdedu.ir/

2

Recruitment center
Name of recruitment center
Counseling Center and Psychological Services of Parnian
Full name of responsible person
Maedeh Khodami
Street address
Beasat, Yazd
City
Yazd
Province
Yazd
Postal code
8919973863
Phone
+98 35 3622 2521
Email
maedehkhodami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University
Full name of responsible person
Dr. Bahram Dalir Naghdeh
Street address
eleven kilometers of University Boulevard- Iran-Urmia,
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
b.dalir@urmia.ac.ir
Web page address
http://www.urmia.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University
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
Urmia University
Full name of responsible person
Mohammad Hossein Sorbi
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Eleven kilometers of University Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
sorbih@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Ali Esazadegan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Eleven kilometers of University Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
009832752741
Email
a.esazade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Mohammad Hossein Sorbi
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Eleven kilometers of University Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
sorbih@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participant Data File: Because the individual data of the study participants are considered, this study shares some of the data such as information about the main outcomes of the study.
When the data will become available and for how long
The access period starts 9 months after the results are published.
To whom data/document is available
The data obtained from this study are only available to researchers working at Urmia University snd Shahid Sadoughi University of Medical Sciences.
Under which criteria data/document could be used
The data of this study are only permitted for correlation analysis and independent t-test.
From where data/document is obtainable
Visit Mr. Mohammad Hossein Sorbi from Urmia University, or contact him by email or phone. Phone: 09131560290, Email: Sorbih@gmail.com
What processes are involved for a request to access data/document
Applicants are required to notify Mr. Sorbi by phone or email 9 months after the results of the study are published. Next, the data will be delivered in person.
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