Evaluation of the photobiomodulation effectiveness in reducing the motor symptoms of Parkinson's disease.
Design
A clinical trial was conducted with a control group and an intervention group, employing a single-blind, randomized design involving 20 patients with Parkinson's disease. Randomization was performed using the "rand" function of Excel software
Settings and conduct
Patients with Parkinson's disease visiting Shahada Tajrish Hospital entered the study voluntarily, providing full consent, unaware of whether they would be assigned to the intervention group or the control group. All individuals involved, except the device operator, remained unaware of whether the radiation was active or inactive during the study.
Participants/Inclusion and exclusion criteria
Males or female between 60 and 80 years with diagnosed idiopathic PD
Hoehn and Yahr stage I to III Stable (unchanged for 6 months) anti-PD medications .
Exclusion criteria
Not capable of self-care, Cognitive impairment defined as <24 on the MoCA
History of significant psychotic episode within the previous 12 months
History of suicidal ideation or attempted suicide within previous 12 months
Taken potentially photosensitizing medication.
History of structural brain disease, active epilepsy, stroke or acute illness, factors affecting gait performance or other severe conditions that would preclude the use of PBM therapy, place the patient at risk during evaluation of their PD, or interfere with the evaluation of their PD.
Intervention groups
In the intervention group, patients with Parkinson's use radiating caps (with 4 LEDs emitting a wavelength of 904 nm and a power of 30 mW) three times a week for a total of 12 sessions. The control group wears the hat without the LEDs being activated.
Main outcome variables
Functional mobility( TUG test)
Dynamic balance
Fine motor skill (Spiral test )
Static balance (TS test ,SLS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240518061830N1
Registration date:2025-04-12, 1404/01/23
Registration timing:prospective
Last update:2025-04-12, 1404/01/23
Update count:0
Registration date
2025-04-12, 1404/01/23
Registrant information
Name
Somayeh Jahani Sherafat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
jahani_somayeh@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the photobiomodulation effectiveness in reducing the motor symptoms of Parkinson's disease
Public title
Evaluation of the photobiomodulation effectiveness in reducing the motor symptoms of Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed idiopathic PD
Hoehn and Yahr stage I to IIIStable (unchanged for 6 months) anti-PD medications
Exclusion criteria:
Inability to take care of yourself
Score less than 24 on the Montreal Cognitive Assessment (MoCA) test
episode of psychosis or suicidal thoughts in the past 12 months
Health problems including: uncontrolled cardiovascular disease, severe joint disease or orthopedic injuries, peripheral neuropathy, vascular occlusive conditions, severe musculoskeletal problems
Conditions that potentially interfere with PBM treatment, such as structural brain disease, epilepsy, or use of potentially photosensitizing medications and tetracycline use
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We generate random numbers using Excel software. Even numbers are assigned to one group and odd numbers to the other. Based on this, we will have a sequence of groupings and after entering the study, patients are assigned to the study groups based on this sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of which group they belong to. The evaluators are also unaware of the patient grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Laser application research center in medical sciences
Street address
Laser application research center in medical sciences,Shahadai Djirish Hospital, Shahadari Street, Djirish Square,Tehran
City
Tehran
Province
Tehran
Postal code
1989934370
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.577
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
ICD-10 code description
https://icd.who.int/browse10/2019/en#/G20
Primary outcomes
1
Description
Timed Up and Go Test: measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning
Timepoint
Before and after 12 sessions of using the laser helmet
Method of measurement
Based on the time recorded by the doctor
Secondary outcomes
1
Description
Functional mobility: Evaluators measure the time it takes for the participant to stand up from a chair, walk 3 meters, turn around a marker, turn around, and sit down.
Timepoint
Before and after completing 12 sessions of wearing a hat
Method of measurement
Timed Up and Go Test (TUG)
2
Description
Static balance
Timepoint
Before and after completing 12 sessions of wearing a hat
Method of measurement
Timed single-leg-stance test (SLST)
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Control group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish hospital
Full name of responsible person
Somayeh Jahani Sherafat
Street address
Laser Application in medical sciences Research center, Shohadaye Tajrish hospital, Shahadari St., Tajrish sq., Tehran.
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Fax
+98 21 2274 9221
Email
jahani_somayeh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Razaghi
Street address
Laser Application in Medical Sciences Research Center, Shahadai Tjirish Hospital - Shahadari St. Tjirish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2274 9221
Email
jahani_somayeh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Jahani Sherafat
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Laser Application in Medical Sciences Research Center, Shahadai Tjirish Hospital - Shahadari St. Tjirish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
009821749221
Email
jahani_somayeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Jahani Sherafat
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Laser Application in Medical Sciences Research Center, Shahadai Tjirish Hospital - Shahadari St. Tjirish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
009821749221
Email
jahani_somayeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Jahani Sherafat
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Laser Application in Medical Sciences Research Center, Shahadai Tjirish Hospital , Shahadari St. Tjirish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2274 9221
Email
jahani_somayeh@sbmu.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
No - There is not 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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The obtained data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For researchers in this field, access to data is provided.
From where data/document is obtainable
Laser Application in Medical Sciences Research Center, Shahadai Tjirish Hospital - Shahadari St. Tjirish Square, Tehran
What processes are involved for a request to access data/document
Submitting a written request to the research center for laser application in medical sciences.