Parkinson DiseaseNCT06916260
Light Therapy Intervention in Individuals With Parkinson's Disease
A study testing Red Light (PDT) in people with Parkinson Disease, run by University of Delaware at 1 site in United States.
Trial summary
The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Red Light (PDT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson disease
Who cannot join
- Participants who are unable to comply with study visit/testing requirements (e.g.
- participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).
- Participants who are unable to provide consent.
- Participants with a Deep Brain Stimulation (DBS) device.
- Participants who have a history of a psychiatric disorder
- Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.
Show all 13Show fewer
- Participants with a clinical diagnosis of PD that is not considered primary (e.g.
- vascular parkinsonism) or participants where an atypical form of parkinsonism is suspected (e.g., progressive supranuclear palsy, multiple system atrophy).
- Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).
- Participants with a history of a recent concussion or any facial, neck, or head injury within the last 6 months. UD IRB Approved: 03/12/2025 IRBNet ID#: 2277769-2 I/C from Rev. 01/2024 Page 3 of 10 Participant's Initial's ________
- Known injury or disease that might interfere with motor function in the proposed experiments (e.g., stroke, traumatic brain injury, extrapyramidal dysfunction, neuromuscular disease, orthopedic problems that impair movement).
- Participants with a history of photosensitivity.
- Participants who are not able to walk unassisted for 2 minutes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roxana Burciu, PhD, Associative Professor contact
United States1 site, 1 recruiting
- Recruiting
University of Delaware STAR Tower
Newark, Delaware, 19711
Sara Penuela, PhD Student, 973-974-0120, penuelas@udel.edu
John Jeka, PdD, jjeka@udel.edu
About this study
The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.
- Conditions
- Parkinson Disease
- Being tested
- Red Light (PDT), Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Light (PDT)Device
The intervention is a non invasive and safe practice. By delivering low level wavelength red light to the front part of the head, it can increase blood flow in the area treated and improve functioning of the associated regions, potentially improving symptoms.
PlaceboDevice
The intervention is a non invasive and safe practice. Participants will be wearing a helmet that delivered low level light therapy to the brain, and use it for the same amount of time as the treatment group. These participants will however, not receive the actual light and receive a placebo, so the helmet will be off. This is done to control of any potential positive effects of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Light therapy grpup | Active comparator | Not described Receives: Device: Red Light (PDT) |
| placebo light therapy | Sham comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive symptom improvement
The investigators want to asses whether light therapy has a positive effect on reducing the cognitive symptoms related with PD, such as loss of short term memory, attention and processing speed. This will be measured using a set of tests and questioners (i.e MoCa, NIH cognitive battery, brief Test of attention (BTA)). Performance on these tests and questioners, which measure diverse aspects of cognition, will be compared before and after the intervention to establish if there is a positive effect of the therapy on any aspect of cognition. The intervention will last a total of 6 weeks right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and cognitive measure changes will be recorded.
Measured: Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.
motor symptoms
The investigators want to asses whether light therapy has a positive effect on reducing the motor symptoms related with PD, such as changes in gait, tremors, and slowing of movement. This will be measured using a set of tests and questioners (i.e MDSUPDRS, Dual task walking, APDM motion capture over a set of tests). Performance on these tests and questioners, which measure diverse aspects of motor capabilities, will be compared before (pre test) and after (post tests) the intervention to establish if there is a positive effect of the therapy on any aspect of motor control and movement. The intervention will last a total of 6 weeks, done right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and any changes in motor measures will be recorded.
Measured: Done immediately before (pre test) and after(post test) intervention lasting about 1 hour. The intervention lasts 6 weeks, so there is about a 6 week period in between the two sessions ( pre and post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start4 Apr 2025 (estimated)
- Primary completion29 Jan 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
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
- Non-randomised
- Intervention model
- Crossover
- Model description
- There will be two groups that receive the light therapy and two that ill receive a placebo treatment to control for any possible effects of the therapy.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroThera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916260
- Sponsor's protocol ID
- 2277769
- Status last verified
- Feb 2025
- First submitted
- 25 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- Light Therapy Intervention in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06916260
- Acronym / sponsor ID
- 2277769
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- NeuroThera
- Study start
- 4 Apr 2025 (estimated)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There will be two groups that receive the light therapy and two that ill receive a placebo treatment to control for any possible effects of the therapy.
| Arm | Type | Receives |
|---|---|---|
| Light therapy grpup | Active comparator | Device: Red Light (PDT) |
| placebo light therapy | Sham comparator | Device: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson disease
Key exclusion criteria (13 listed)
- Participants who are unable to comply with study visit/testing requirements (e.g.
- participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).
- Participants who are unable to provide consent.
- Participants with a Deep Brain Stimulation (DBS) device.
- Participants who have a history of a psychiatric disorder
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 |
|---|---|---|
| Red Light (PDT)The intervention is a non invasive and safe practice. By delivering low level wavelength red light to the front part of the head, it can increase blood flow in the area treated and improve functioning of the associated regions, potentially improving symptoms. | Device | Light therapy grpup |
| PlaceboThe intervention is a non invasive and safe practice. Participants will be wearing a helmet that delivered low level light therapy to the brain, and use it for the same amount of time as the treatment group. These participants will however, not receive the actual light and receive a placebo, so the helmet will be off. This is done to control of any potential positive effects of the therapy. | Device | placebo light therapy |
Primary outcome
cognitive symptom improvement
Time frame: Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.
The investigators want to asses whether light therapy has a positive effect on reducing the cognitive symptoms related with PD, such as loss of short term memory, attention and processing speed. This will be measured using a set of tests and questioners (i.e MoCa, NIH cognitive battery, brief Test of attention (BTA)). Performance on these tests and questioners, which measure diverse aspects of cognition, will be compared before and after the intervention to establish if there is a positive effect of the therapy on any aspect of cognition. The intervention will last a total of 6 weeks right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and cognitive measure changes will be recorded.
motor symptoms
Time frame: Done immediately before (pre test) and after(post test) intervention lasting about 1 hour. The intervention lasts 6 weeks, so there is about a 6 week period in between the two sessions ( pre and post)
The investigators want to asses whether light therapy has a positive effect on reducing the motor symptoms related with PD, such as changes in gait, tremors, and slowing of movement. This will be measured using a set of tests and questioners (i.e MDSUPDRS, Dual task walking, APDM motion capture over a set of tests). Performance on these tests and questioners, which measure diverse aspects of motor capabilities, will be compared before (pre test) and after (post tests) the intervention to establish if there is a positive effect of the therapy on any aspect of motor control and movement. The intervention will last a total of 6 weeks, done right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and any changes in motor measures will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Roxana Burciu, PhD, Associative Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Light (PDT) in people with Parkinson Disease, run by University of Delaware at 1 site in United States.
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 1 inclusion and 13 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: looking for participants now, 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Penuela, PhD student (9739740120, penuelas@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive symptom improvement (time frame: Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.). The study lists 2 primary outcomes in all. 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.