Protocol summary

Study aim
The goal of this study is to empower Parkinson's disease by reducing the motor and non-motor symptoms of the disease, affecting brain connections, and strengthening the brain's dopaminergic pathways.
Design
The clinical trial is without a control group and patients are divided into two groups in a single-blinded manner (patients are unaware of the type of glove) using the randn command of the Matlab software, and 3 of them start the intervention with the original glove and the other 3 with the dummy glove. After one month, the gloves are changed between the patients.
Settings and conduct
EEG data collection from patients is done in the brain mapping laboratory and UPDRSIII score is taken at Hazrat Rasool Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: While taking the medication, have been diagnosed with typical Parkinson's disease according to Hoehn and Yahr stage 2 to 4 criteria - Inclusion criteria: Cannot have dopamine dis regulation syndrome or other neurological diseases such as major depression, dementia, attention deficit disorder, psychosis or essential tremor. Patients cannot have severe sensory abnormalities of the fingertips such as vibratory urticaria. Patients who are pregnant, breastfeeding or trying to become pregnant during the study period are excluded from the study. Patients must not have a history of multiple sclerosis (MS), Alzheimer's, hip fracture, total knee or hip replacement surgery, Huntington's disease and a history of stroke.
Intervention groups
The number of participants is 6. The intervention is such that from the beginning of the study, patients undergo a medical examination and visit with a neurologist for 1 month, and in the following month,
Main outcome variables
Effect on motor neuron plasticity; reduction of neuronal synchronization; reduction of Parkinson's disease symptoms; improvement of the patient's quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250922067329N1
Registration date: 2025-10-21, 1404/07/29
Registration timing: prospective

Last update: 2025-10-21, 1404/07/29
Update count: 0
Registration date
2025-10-21, 1404/07/29
Registrant information
Name
Aboozar Moradi
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 1508
Email address
amoradi1981@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Empowering Parkinson's patients with vibrational Coordinated Reset method
Public title
Studying the effect of vibrating gloves on reducing symptoms of Parkinson's disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients participating in this trial are between 45 and 85 years old. While taking the medication, Parkinson's disease was diagnosed with Hoehn and Yahr stage 2 to 4 criteria. Patients must communicate clearly with staff and speak Persian.
Exclusion criteria:
Patients cannot have dopamine dis regulation syndrome or the presence of other neurological diseases such as major depression, dementia, attention deficit disorder, psychosis, or essential tremor. Patients cannot have a history of epilepsy, traumatic brain injury, or brain surgery. Patients cannot have severe sensory abnormalities of the fingertips, such as vibratory urticaria. They were excluded from the study if they were currently using psychotropic or narcotic medications or taking medications that affect brain function that would alter recorded EEG activity (such as anticonvulsant, ADHD, depression, or anxiety medications). Patients who are pregnant, lactating, or trying to become pregnant during the study period will be excluded from the study. Also, according to the selected TUG task, patients should not have a history of multiple sclerosis (MS), Alzheimer's, hip fracture, total knee or hip replacement surgery, Huntington's disease, and a history of stroke.
Age
From 45 years old to 85 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 6
More than 1 sample in each individual
Number of samples in each individual: 9
For each individual, an electroencephalography sample is taken with a 32 channel Nautilus helmet, the description of which is included in the message to the referee, for 9 sessions, and we use the Matlab software to analyze it.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Two gloves, one as a dummy glove with no effect and one as a real glove that affects the disease, are randomly provided to patients. During the study, two gloves are used for each patient, one of which is a sham, and the patient and the clinical caregiver do not know whether the dummy glove or the real glove was received first.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Department of Research and Technology Central Headquarters Building Iran University of Medical Sciences Adjacent to Milad Tower,Hemmat Highway Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-09-03, 1404/06/12
Ethics committee reference number
IR.IUMS.REC.1404.569

Health conditions studied

1

Description of health condition studied
Idiopathic Parkinson’s
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
EEG connectivity
Timepoint
We have an EEG data acquisition as initial data from the patient, 14 days later the glove is delivered and data is collected on the same day, the next day-15th day data is collected to examine the short-term effect, then 2 weeks later, 14 days after delivery, we will have another data collection session, and finally 30 days after delivery, we will have another session. Then the Sham glove will be delivered and 3 data collection sessions will be taken in the first month, the middle of the month, and the end of the month, which will ultimately have 8 data collection sessions.
Method of measurement
EEG data acquisition is performed with the help of a portable device at the National Brain Mapping Laboratory. For each patient, two weeks before the start of the study, a 10-minute EEG is taken during a standard cognitive TUG task with a vibrating glove.Then, after two weeks, data collection is repeated. First, 10 minutes without stimulation are taken before data collection, and then the glove is worn by the patient and 10 minutes of EEG data collection is performed with the vibrating glove stimulation during the TUG task. Then, data is collected from the patient again for 10 minutes without gloves during the TUG task. This will be a data collection session.The next day, data collection is also collected in the same way. Then the glove will be provided to the patient. Then, 2 weeks after the glove is delivered, we will have an EEG data collection session on the same day. Finally, we will have a data collection session 2 weeks later. In this way, in the first month, we will have 4 half-hour EEG data collection sessions from the patient. Then, we perform the same procedure in the second month with the Sham glove, which will be a total of 9 sessions in 2 months and 2 weeks, collecting data from the patient.

2

Description
UPDRS-III
Timepoint
Before each EEG session, the patient's ,UPDRS-III is taken once, for a total of 8 times.
Method of measurement
This variable is taken by a neurologist - the project consultant - from patients in the neurology clinic of Hazrat Rasool Akram Hospital.

3

Description
PDQ-39 Questionnaire
Timepoint
Each time the UPDRS-III is taken from patients, the questionnaire will be filled out once. In total, we will have 7 questionnaires from patients.
Method of measurement
The patient sits next to the researcher and answers the questions, which the researcher records on a response sheet. This is a standardized form validated by Oxford University.

Secondary outcomes

1

Description
Comparison of EEG connectivity before and after using with gloves
Timepoint
Once the data is collected, a meaningful comparison analysis is performed.
Method of measurement
By comparing the brain connectivity matrix before and after the intervention, connectivity should be reduced on average.

2

Description
Comparison of UPDRS-III score before and after intervention with effect size criterion and t-test statistical test
Timepoint
Once after data collection, every 7 data collection times are examined with the pre-intervention state for these statistical criteria.
Method of measurement
The UPDRS-III score before and after the intervention is examined using t-test and Anova-test statistical tests to determine the effect size of the intervention.

3

Description
Comparison of PDQ-39 scores before and after intervention using t-test and Anova-test statistical tests.
Timepoint
Once after data collection, every 7 data collection times are examined with the pre-intervention state for these statistical criteria.
Method of measurement
The PDQ-39 score before and after the intervention is examined using t-test and Anova-test statistical tests to determine the effect size of the intervention.

Intervention groups

1

Description
Intervention group: A group of 3 patients who have been provided with the original gloves.Then, after a month of using the original glove, they receive the sham glove.We do not have a control group.
Category
Rehabilitation

2

Description
Intervention group: A group of 3 patients who are given sham gloves. Then after a month of using the sham gloves, they receive the original gloves. We do not have a control group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasul Akram educational, research and treatment complex
Full name of responsible person
Dr. Mohammad Rouhani
Street address
No. Corner of Mansouri Street, Niayesh Street, Sattarkhan Street Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 933 980 0850
Email
Rasoolhospital@iums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Dr. Manouchehr (Hadi) Moradi Sabzevar
Street address
Vice Presidency for Research and Technology, Central Campus, University of Tehran, 16 Azar St., Enqelab St., Enqelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6640 0059
Email
research@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Tehran
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
The University of Tehran
Full name of responsible person
Aboozar Moradi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No. 1, 5th Floor, Block 9, Shahid Chamran Residential Complex, Nobonyad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957978198
Phone
+98 21 2610 1508
Email
amoradi1981@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Aboozar Moradi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No. 1, 5th Floor, Block 9, Shahid Chamran Residential Complex, Nobonyad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957978198
Phone
+98 21 2610 1508
Email
amoradi1981@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Aboozar Moradi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No. 1, 5th Floor, Block 9, Shahid Chamran Residential Complex, Nobonyad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957978198
Phone
+98 21 2610 1508
Email
amoradi1981@ut.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
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
Not applicable
Title and more details about the data/document
Age, gender, and duration of Parkinson's disease will be included in a table in articles submitted to reputable international journals. The study protocol, statistical analysis plan, informed consent form, clinical study report, and codes used in the MATLAB environment will also be included in the article.
When the data will become available and for how long
After the articles are published, research information in most articles will be made available to experts and researchers. Approximately 9 months after the research
To whom data/document is available
The general public, researchers, and patients can use its information.
Under which criteria data/document could be used
This research data can be used without preconditions for continued research in this field and for the use of researchers and physicians.
From where data/document is obtainable
They can obtain the necessary information on the official website of the published articles.
What processes are involved for a request to access data/document
Go to the article publishing website and download it or email the research manager and receive the required information.
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