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The Effect of Transcranial Direct Current Stimulation on Balance in People with Parkinson’s Disease

Protocol summary

Study aim
comparision the effect of several target of transcranial direct current stimulation (tDCS) including M1, DLPFC and M1-DLPFC on balance in people with Parkinson's disease (PD)
Design
Double blind Cross-over trial. block randomization
Settings and conduct
This study will be conducted in Parkinson's disease association in Isfahan. 25 patients with PD will recieve four conditions include M1, DLPFC, M1-DLPFC, and sham in a counterbalance random order
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) Patients with Parkinson's Disease (2) Age 40 or older (3) Stages 2,3 on the Hoehn and Yahr scale (4) Ability to walk independently for at least 10 m (5) Montreal Cognitive Assessment score ≥ 24 (6) No change in medication prescription during and since 3 weeks before the study Exclusion criteria: (1) Any deformity of the lower limbs (2) using central nervous system medications other than for PD, e.g., antiepileptic or antidepressant drugs (3) Contraindications of using tDCS, such as having metal implants in the head, pacemaker, pregnancy, history of brain damage, history of epilepsy and seizures, and intermittent headaches (4) patients with neurological diseases other than PD, psychiatric diseases, or patients with drug or alcohol abuse.
Intervention groups
the active set-up, the tDCS device will apply a constant current of for 20 minutes. the intensity of tDCS will be 3 mA. For M1 stimulation, The anode will be place over Cz and the cathode will be applied over the left shoulder. For DLPFC stimulation, anode and cathode electrodes will be placed over F3 and right shoulder respectively. The sham tDCS set-up will receive the same electrode placement and duration of stimulation, but the device will be turned off after 30 seconds.
Main outcome variables
Before/after Berg balance scale; Mini-BESTest; Timed Up and Go(single/dual task)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240902062940N1
Registration date: 2024-12-08, 1403/09/18
Registration timing: registered_while_recruiting

Last update: 2024-12-08, 1403/09/18
Update count: 0
Registration date
2024-12-08, 1403/09/18
Registrant information
Name
Negar Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5000
Email address
negar.zare.789@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-30, 1403/07/09
Expected recruitment end date
2025-02-27, 1403/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Transcranial Direct Current Stimulation on Balance in People with Parkinson’s Disease
Public title
The Effect of Transcranial Direct Current Stimulation on Balance in People with Parkinson’s Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with PD by a neurologist Age 40 or older Stages 1–3 on the Hoehn and Yahr scale Ability to walk independently for at least 10 m without using walking aids A score of ≥ 24 on Montreal Cognitive Assessment (MoCA-P) No change in medication prescription 3 weeks prior to study and during the study
Exclusion criteria:
ny deformity of the lower limbs(2) using central nervous system medications other than for PD, e.g., antiepileptic or antidepressant drugs (3) Contraindications of using tDCS, such as having metal implants in the head, pacemaker, pregnancy, history of brain damage, history of epilepsy and seizures, and intermittent headaches (4) patients with neurological diseases other than PD, psychiatric diseases, or patients with drug or alcohol abuse.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
All participants will be randomly assigned to a 4*25 block randomization, using a web-based randomization system (http://www.randomization.com) and will recieve all four stimulation conditions, including real M1+DLPFC tDCS, real M1 tDCS, real DLPFC tDCS and sham tDCS.
Blinding (investigator's opinion)
Double blinded
Blinding description
To ensure blinding of participants, the stimulating apparatus will be positioned out of sight and as for investigator blinding, the stimulation or sham protocol will be applied by another expert.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Rehabilitation faculty Isfahan university of medical science, Hezar jarib street
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2024-08-20, 1403/05/30
Ethics committee reference number
IR.MUI.REC.1403.015

Health conditions studied

1

Description of health condition studied
People with Parkinson's Disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Berg balance scale score
Timepoint
before/after intervention
Method of measurement
Berg Balance Scale

2

Description
the score of Mini-BESTest (Balance Evaluation Systems Test)
Timepoint
before/after intervention
Method of measurement
Mini-Balance Evaluation Systems Test

3

Description
Timed Up and Go Test
Timepoint
before/after intervention
Method of measurement
Timed Up and Go Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: each participant receives four sessions ofactive set-up, the tDCS device will apply a constant current of for 20 minutes with the ramp up-ramp down duration of 30 sec. the intensity of tDCS will be 3 mA The current will be delivered through four saline-soaked surface electrodes measuring 5x7 cm, connected to a direct current stimulator. Channel A of the device will be used for M1 stimulation. The anode will be place over Cz and the cathode will be applied over the left shoulder. For DLPFC stimulation, anode and cathode electrodes of channel B will be placed over F3 and right shoulder respectively.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation faculty
Full name of responsible person
Dr. Javid Mostamand
Street address
Rehabilitation faculty, Isfahan University of medical science, Hezar jarib stree
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
negar.zare.789@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Javid Mostamand
Street address
Rehabilitation faculty, Isfahan University of medical science, Hezar jarib street
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
negar.zare.789@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
DR. Javid Mostamand
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
hezarjarib
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
negar.zare.789@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
DR. Javid Mostamand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
rehab faculty, Isfahan university of medical science, Hezarjerib st
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
negar.zare.7892@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Javid Mostamand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
rehab faculty, Isfahan university of medical science, Hezarjerib st
City
isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
negar.zare.789@gmail.com

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
Yes - There is 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
Yes - There is 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
some data will be published
When the data will become available and for how long
6 month after publishing the articles
To whom data/document is available
academic staff
Under which criteria data/document could be used
for research
From where data/document is obtainable
negar.zare.789@gmail.com
What processes are involved for a request to access data/document
sending an email to corresponding person
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