1. Home
  2. Approved trials
  3. » فارسی

Evaluation the effect of transcranial stimulation of the primary motor cortex (M1) in comparison with the transcranial stimulation of the primary motor cortex (M1) and the left dorsolateral prefrontal cortex (F3) on the bio-physiological and psychological status of patients with type 2 diabetes with neuropathic pain

Protocol summary

Study aim
Determining the difference between the effect of transcranial stimulation of cortex M1 with the effect of transcranial stimulation of cortex M1 and F3 on the bio-physiological and psychological status of patients with type 2 diabetes with neuropathic pain
Design
Clinical trial with sham-control group, with parallel groups, double-blind, randomized, on 30 patients. Excel software rand function will be used for randomization
Settings and conduct
The place of the study will be the Bonab Diabetes Association; the study population will be all diabetic patients aged 30 to 55 years with neuropathic pain, who is a member of Bonab Diabetes Association in the summer 2021; Type of blinding: double-blind; The blinding technique: in this study, the transcranial brain stimulation device will be in the postdoctoral researcher's room (Roghayeh Mohammadi) and only she will be aware of the type of intervention for each person. In this study, diabetic patients in all three groups, clinical caregivers and outcome assessors will not know the type of intervention assigned to each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least 3 year history of diabetes; Having neuropathic pain; Not receiving psychological treatment since the diagnosis. Non-inclusion criteria: pacemaker
Intervention groups
Intervention group 1: anodic tDCS group of primary motor cortex (M1) , Intervention group 2: anodic tDCS group of primary motor cortex (M1) and the left dorsolateral prefrontal cortex (F3) , Control group: placebo
Main outcome variables
HB a1c content; Glucagon; Insulin; Cortisol, Metanephrine; Normetanephrine; Number of white blood cells; Number of red blood cells; Number of Platelet; Anxiety; Stress; Depression; Pain rate; Sleep Quality; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210214050363N1
Registration date: 2021-06-14, 1400/03/24
Registration timing: prospective

Last update: 2021-06-14, 1400/03/24
Update count: 0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Ahmad Alipoor
Name of organization / entity
Payam-e-Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 5747
Email address
alipor@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of transcranial stimulation of the primary motor cortex (M1) in comparison with the transcranial stimulation of the primary motor cortex (M1) and the left dorsolateral prefrontal cortex (F3) on the bio-physiological and psychological status of patients with type 2 diabetes with neuropathic pain
Public title
The effect of tDCS on the treatment of neuropathic pain in diabetics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 3 year history of diabetes Having neuropathic pain Not receiving psychological treatment since the diagnosis Having at least middle school education Being right-handed
Exclusion criteria:
Acute psychological illness Having a pacemaker or intracardiac defibrillator
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In the present research, randomization will be block, and the randomization unit will be cluster. First, random assignment of patients (30 individuals) to 3 groups (first 10 patients for group A, then 10 patients for group B, and finally 10 patients for group C), is performed using the command to generate integer random numbers (INT = (RAND) * 30) the rand function of Excel software. After random assignment of patients to 3 groups, in the next step, random assignment of intervention type to three groups A, B, and C will be performed. Groups (intervention group 1; primary motor cortex stimulation (M1), intervention group 2; primary motor cortex stimulation (M1) and the left dorsolateral prefrontal cortex (F3), control group; placebo) will be written on three pieces of paper and will be folded, then, by randomly selecting the first paper from the three papers, the type of intervention of group A will be determined by selecting the second paper from the remaining two papers, the type of intervention of group B will be determined and the remaining third paper will determine the type of intervention for group C.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is done double blindly. Because the device will be in the postdoctoral researcher's room (Roghayeh Mohammadi) and only she will be aware of the type of intervention for each person. In this study, in fact, diabetic patients in all three groups, clinical caregivers (nurse and the researcher's assistant psychologist who will be out of the room), and outcome assessors (both at the association and in the blood test laboratory), will not know the type of intervention assigned to each of the 3 groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Payam-e-Noor University
Street address
Graduate Studies Center of Payame Noor University, Safa Alley, Shahnaz Alley, Shahid Haj Mahmoud Nourian St., North Dibaji St., Farmanieh St.
City
Tehran
Province
Tehran
Postal code
1953633511
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.PNU.REC.1399.132

Health conditions studied

1

Description of health condition studied
Neuropathic pain in diabetes
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Pain score on the McGill Pain Scale
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
the McGill Pain Scale

2

Description
HB A1c
Timepoint
Measurement of HB a1c before the study (last test in two-three months before the intervention), immediately after the last intervention session, 3 months after the intervention
Method of measurement
blood test

3

Description
Glucagon
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

4

Description
Insulin
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

5

Description
Cortisol
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

6

Description
metanephrine
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

7

Description
normetanephrine
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

8

Description
white cell count
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

9

Description
red blood cell count
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
blood test

10

Description
Platelets
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
Platelets blood test

11

Description
Depression
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
The Depression Anxiety Stress Scale- DASS- 42

12

Description
Anxiety
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
The Depression Anxiety Stress Scale- DASS- 42

13

Description
sleep quality
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
Pittsburgh Standard Sleep Quality Questionnaire

14

Description
Quality of Life
Timepoint
Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention
Method of measurement
Questionnaire 36 questions quality of life

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Primary motor cortical anodic tDCS group of the brain (M1); the group receives 12 sessions, 3 days a week; each session will last 40 minutes (20 minutes left M1 stimulation and 20 minutes right M1 stimulation) in that patients will receive transcranial direct current stimulation (tDCS) for the M1 region with 2 mA electrical current.
Category
Treatment - Devices

2

Description
Intervention group 2: Primary motor cortical anodic tDCS group of the brain (M1) and the anodic tDCS of the left dorsolateral prefrontal cortex (F3); this group receives 12 sessions, 3 days a week. Therr will be 20 minutes of M1 anodic tDCS (10 minutes left M1 stimulation and 10 minutes of right M1 stimulation) and 20 minutes of F3 region anodic tDCS (left DLPFC) with 2 mA electrical current in each session.
Category
Treatment - Devices

3

Description
Control group: placebo; for this group, the tDCS device, equipped with the default settings for sham stimulation, will provide real stimulation for 20 seconds, then despite remaining of the anode pad on M1 region for 20 minutes and F3 region for 20 minutes, the real stimulation will not happen for these regions.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bonab County Diabetes Association
Full name of responsible person
Ashraf Sattarfam
Street address
Daneshjoo Street
City
Bonab
Province
East Azarbaijan
Postal code
5551744379
Phone
+98 41 3772 7565
Email
mohammadi.rogayeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payam-e-Noor University
Full name of responsible person
Dr. Mohammad Ali Karimi
Street address
Payame Noor University Central Organization, Nakhl St., at the beginning of Naft Town, Artesh Boulevard, Mini City,
City
Tehran
Province
Tehran
Postal code
4697-19395
Phone
+98 21 2332 0000
Email
mohammadi.rogayeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Independently by researchers
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
PayameNoor university
Full name of responsible person
Rogayeh mohammadi
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Niayesh 7 Alley, Banafsheh Alley, Imam Street
City
Bonab
Province
East Azarbaijan
Postal code
5551744379
Phone
+98 41 3773 0075
Email
rogayeh.mohammadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
PayameNoor university
Full name of responsible person
Rogayeh Mohammadi
Position
پژوهشگر پسادکتری
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Imam Street - Banafsheh Alley - Niayesh Alley 7
City
Bonab
Province
East Azarbaijan
Postal code
5551744379
Phone
+98 41 3773 0075
Email
rogayeh.mohamadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
PayamNoor university
Full name of responsible person
Ahmad Alipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Farmaniyeh
City
Tehran
Province
Tehran
Postal code
1953633511
Phone
+98 21 2229 5747
Fax
+98 21 2280 8494
Email
alipor@pnu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All data can be shared after de-identification of the individuals.
When the data will become available and for how long
En Access period starts 4 months after publishing the results.
To whom data/document is available
En Both for employed researchers in academic and scientific institutions and for people working in the industry.
Under which criteria data/document could be used
En Any scientific and humanitarian use in order to help to relieve patients' neuropathic pain will be allowed.
From where data/document is obtainable
Refer to Dr. Roghayeh Mohammadi by contact number: 00989141221070 and by email: rogayeh.mohammadi@gmail.com
What processes are involved for a request to access data/document
En In case of presenting introduction, reliable documents, and stating the purpose of obtaining the data, the requested data will be emailed to the applicant in a short time.
Comments
Loading...