Protocol summary
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Study aim
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Determining the effect of adding tDCS of supplementary motor area to exercise therapy on quality of life, walking, balance, proprioceptive processing and brain electrical activity of Parkinson's patients.
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Design
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 30 patients. Randomization using sealed envelopes
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Settings and conduct
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This research will be done in Tarbiat Modares University. Patients are randomly divided into one of two groups, sham and intervention, and then they undergo the evaluations of the previous session, 6 intervention sessions related to their group, and after that, they are evaluated later. The patients were blinded to the group assignment. Patients in the sham group receive tDCS intervention only for the first 30 seconds, despite observing that the lamps of the device are on. Receiving this intervention is not perceptible in the head area. The analyzer also analyzes the results with unknown codes from the grouping.
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Participants/Inclusion and exclusion criteria
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inclusion:
1. Idiopathic Parkinson's patients (male and female)
2. H&Y criterion: between 2-3.
3. Walking without assistance
4. Age between 35 and 75
exclusion:
1. Existence of specific musculoskeletal, cardiorespiratory, balance, and vision
2. Having diabetes
3. Having neuropathy
4. Neurological problem other than Parkinson's
5. Body mass index of 30 or more
6. Mini-Mental State Exam score less than 24
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Intervention groups
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Test group: 6 sessions in one day between tDCS with a current intensity of 2 milliamps for 20 minutes on the supplementary motor area and then 5 balance exercises and therapeutic exercise.
Control group: 6 therapeutic exercise sessions one day in between. In addition, sham tDCS is also used for 20 minutes in the sessions of these people
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Main outcome variables
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proprioceptive acuity
General information
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Reason for update
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The researchers of this trial would like to request a modification in the blinding section of the study. Previously, it was announced that the study would be double-blind (participants and data analysts), which had been approved. However, during data analysis, the researchers suspected issues in the analysis process and, upon re-evaluation, inevitably became aware of the relationship between the results and the groups. This has led to the study being changed from double-blind to single-blind (only participants).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230820059201N2
Registration date:
2024-06-04, 1403/03/15
Registration timing:
prospective
Last update:
2025-05-24, 1404/03/03
Update count:
1
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Registration date
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2024-06-04, 1403/03/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-21, 1403/04/01
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Expected recruitment end date
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2025-03-18, 1403/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Adding Trans-Cranial Direct Current Stimulation on Supplementary Motor Area to Exercise Therapy on Proprioception Acuity, Postural Control, Initiation of Gait, and Brain Cortical Activity in People with Parkinson’s
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Public title
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Investigation of effect of tDCS application before exercise therapy on proprioception accuracy in people with Parkinson's
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1. Idiopathic Parkinson's patients (men and women) diagnosed by a neurologist according to the UK Brain Bank Criteria; 2. H&Y criteria of patients should be between 2 and 3; 3. have the ability to walk without assistance; 4. be treated with a fixed dose of dopaminergic drugs during the process of evaluation and therapeutic exercise and re-evaluation; 5. Be able to perform simple verbal commands.
Exclusion criteria:
1. Existence of specific musculoskeletal, cardiorespiratory, balance, vision, or cognitive disorders that affect the patient's performance of tests and exercises and walking; 2. having diabetes; 3. According to the opinion of the neurologist, the patient has evidence of neuropathy; 4. The existence of another neurological problem other than Parkinson's; 5. have undergone surgery that affects their walking; 6. Participating in regular exercise therapy programs during the last 6 months; 7. Using aids for walking; 8. Having a body mass index of 30 or more; 9. Mini-Mental State Exam score less than 24
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Age
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From 35 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After the participants entered the study according to the entry and exit conditions, using sealed envelopes in three pots (blocks) related to the age groups determined by the World Health Organization (young: 25 to 44 years old, middle-aged: 44 to 60 years old) , and elderly: 60 to 75 years) is done. Finally, the patients are entered into the test group (tDCS + exercise therapy) or the control group (sham tDCS + exercise therapy). To remove the effect of old age, the age distribution in two groups will be normalized as follows:
Each of the three pots contains 10 envelopes (5 envelopes for the control group and 5 envelopes for the intervention group). Each participant takes the envelope from the pot corresponding to his age, depending on the age range he is in.
Patients of each group are unaware of which group they belong to.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patients do not see the results of the randomization process and each group is unaware of which group they have been placed in.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-03-13, 1402/12/23
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Ethics committee reference number
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IR.MODARES.REC.1402.258
Health conditions studied
1
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Description of health condition studied
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Parkinson disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinsonism or Parkinson disease: -NOS -idiopathic -primary
Primary outcomes
1
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Description
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- Quality of life score in the quality of life questionnaire of Parkinson's patients - Faster and more stable start of walking on force plate - Postural stability in quiet standing on force plate - Accuracy of proprioceptive processing in functional and non-functional activities in the start of movement measurement device and position sense tests - the electrical activity of the brain in the processing of proprioceptive information in the electroencephalography
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Timepoint
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Measure the mentioned criteria at the beginning of the study and then 48 hours after the sixth treatment session
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Method of measurement
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- Parkinson's patients' quality of life questionnaire -force plate -the device for measuring the sense of the start of movement -tests to measure the accuracy of joint position sense -electroencephalography
Intervention groups
1
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Description
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Intervention group: 6 sessions in one day between trans-cranial direct current stimulation with a current intensity of 2 milliamps for 20 minutes on the supplementary motor area and then 5 balance exercises
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Category
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Rehabilitation
2
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Description
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Control group: 6 sessions of balance training in one day. In addition, sham tDCS is also used for 20 minutes in the sessions of these people.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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by contacting corresponding author after article publishing
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When the data will become available and for how long
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َAfter article publishing
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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doing research, preparing related products
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From where data/document is obtainable
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corresponding author of the article
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What processes are involved for a request to access data/document
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Send a request to the corresponding author of the article,
Review by the corresponding author.
data will be sent via email
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Comments
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