- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06729125
Transcranial Photobiomodulation With Patients With Parkinson's Disease
April 6, 2025 updated by: Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
Posture Stability and Functional Activity Changes After Transcranial Photobiomodulation for Patients With Parkinson's Disease: A Randomized Controlled Trial
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease.
It is a progressive and disabling disease with significative impact on quality of life.
Since it has no cure, available treatment is targeted to improve the symptoms due to a lack of dopamine in the central nervous system.
The aim of the study was to see how transcranial photobiomodulation (tPBM) helped patients with Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amaan, Jordan
- Al Zaytoonah University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- idiopathic PD,
- Hoehn & Yahr stage I-IV,
- independent gait with or without technical assistance
- stable parkinsonian medication for at least a month before the study star.
Exclusion Criteria:
- comorbidities that affect balance or walking,
- other neurological pathologies besides PD,
- chronic diseases not medically controlled and participation in another physiotherapy program or sport activity during the intervention period or in the month before starting the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
|
balance exercises and others
|
|
Experimental: study group
|
Single-session transcranial laser stimulation was administered with a continuous-wave, 1,064-nm laser (Model CG-5000 Laser, Cell Gen Therapeutics LLC, Dallas, TX).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
posture stability
Time Frame: 8 weeks
|
The Biodex Balance System (Biodex Medical Systems Inc, USA) Will be used to assess the limit of stability (overall, forward and backward) pre- and post-treatment.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional activity
Time Frame: 8 weeks
|
The modified Parkinson activity scale (mPAS) consist of 14 items arranged on to three domains: chair transfer (2 items), gait akinesia (6 items) and bed mobility (6 items)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2024
Primary Completion (Actual)
March 20, 2025
Study Completion (Actual)
April 3, 2025
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 10, 2024
First Posted (Actual)
December 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD , LASER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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