Parkinson DiseaseNCT06729125
Transcranial Photobiomodulation With Patients With Parkinson's Disease
A study testing transcranial photobiomodulation and exercises training in people with Parkinson Disease, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- transcranial photobiomodulation and exercises training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteJordan
- Study dates
- 15 Dec 2024to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- transcranial photobiomodulation, exercises training
- Keywords
- transcranial photobiomodulation, posture instability, Parkinson's disease, modified Parkinson activity scale, Biodex balance system
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial photobiomodulationDevice
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).
exercises trainingOther
balance exercises and others
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Device: transcranial photobiomodulation |
| control group | Active comparator | Not described Receives: Other: exercises training |
What is being measured
The primary outcome is the main question the study is designed to answer.
posture stability
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.
Measured: 8 weeks
Secondary outcomes (1)
functional activity
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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024
- Primary completion20 Mar 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729125
- Sponsor's protocol ID
- PD , LASER
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Stability and Functional Activity Changes After Transcranial Photobiomodulation for Patients With Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06729125
- Acronym / sponsor ID
- PD , LASER
- Conditions
- Parkinson Disease
- Keywords
- transcranial photobiomodulation, posture instability, Parkinson's disease, modified Parkinson activity scale, Biodex balance system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: transcranial photobiomodulation |
| control group | Active comparator | Other: exercises training |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial photobiomodulationSingle-session transcranial laser stimulation was administered with a continuous-wave, 1,064-nm laser (Model CG-5000 Laser, Cell Gen Therapeutics LLC, Dallas, TX). | Device | study group |
| exercises trainingbalance exercises and others | Other | control group |
Primary outcome
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.
1 secondary outcome
functional activity
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial photobiomodulation and exercises training in people with Parkinson Disease, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
posture stability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.