Parkinson DiseaseNCT03811613
Photobiomodulation and Parkinson
A study testing Transcranial photobiomodulation in people with Parkinson Disease, run by University of Oviedo at 2 sites in Spain.
Trial summary
This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesSpain
- Study dates
- 29 Jan 2018to 30 Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having been diagnosed with idiopathic PD.
- Stage 1-2 on the Hoehn and Yahr Scale.
- Having no neurological condition other than PD.
- Being able to stand for 2 minutes and walk 10 meters without assistance.
- Having no severe dyskinesias or "ON-OFF" phases.
Who cannot join
- Do not follow inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Department of Physical Education and Sport, University of León
León, Castille and León, 24071
University School of Sports Medicine, University of Oviedo, Spain.
Oviedo, Principality of Asturias, 33005
About this study
Official title: Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).
Read the detailed description
Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17, [mean±SD] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking ability (ten-meter walk test [TMWT]) and functional mobility (timed up and go [TUG] test).
- Conditions
- Parkinson Disease
- Being tested
- Transcranial photobiomodulation
- Keywords
- movement disorders, light therapy, motor aspects
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial photobiomodulationOther
Also called LEDs
Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Experimental | 17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group).
Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks. Receives: Other: Transcranial photobiomodulation |
| Sham group | Sham comparator | 18 Parkinson´s disease patients were randomly assigned to the sham group.
Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group). Receives: Other: Transcranial photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The motor portion of the MDS-UPDRS.
The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale. It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).
Measured: 9 weeks
Secondary outcomes (4)
Motor function
The Spanish-validated version of the Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in PD (SCOPA). It measures the Parkinson´s disease patients motor function (minimum and maximum score is 0 and 63 points respectively -the higher score, the worse motor function and vice versa-).
Measured: 9 weeks
Static posturography
The centre of pressure (CoP) parameters (these CoP parameters; Length in mm, Area in mm2 and Speed in m/s are combined to report the static posturography).
Measured: 9 weeks
Walking speed
Ten-meter walk test
Measured: 9 weeks
TUG
Timed up and go test
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start29 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Santos, University of Oviedo
- Investigators
- Luis Santos, PhD, Principal investigator, Department of Physical Education and Sport (University of León, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811613
- Sponsor's protocol ID
- #08/18
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Santos L, Olmo-Aguado SD, Valenzuela PL, Winge K, Iglesias-Soler E, Arguelles-Luis J, Alvarez-Valle S, Parcero-Iglesias GJ, Fernandez-Martinez A, Lucia A. Photobiomodulation in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2019 May-Jun;12(3):810-812. doi: 10.1016/j.brs.2019.02.009. Epub 2019 Feb 20. No abstract available.
PubMed 30824206
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03811613
- Acronym / sponsor ID
- #08/18
- Conditions
- Parkinson Disease
- Keywords
- movement disorders, light therapy, motor aspects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 22 Jan 2019 (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.
This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).
Detailed description
Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17, [mean±SD] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking ability (ten-meter walk test [TMWT]) and functional mobility (timed up and go [TUG] test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Other: Transcranial photobiomodulation17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group). Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks. |
| Sham group | Sham comparator | Other: Transcranial photobiomodulation18 Parkinson´s disease patients were randomly assigned to the sham group. Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Having been diagnosed with idiopathic PD.
- Stage 1-2 on the Hoehn and Yahr Scale.
- Having no neurological condition other than PD.
- Being able to stand for 2 minutes and walk 10 meters without assistance.
- Having no severe dyskinesias or "ON-OFF" phases.
Key exclusion criteria (1 listed)
- Do not follow inclusion criteria.
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 photobiomodulationAlso: LEDsPhotobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull) | Other | Photobiomodulation group, Sham group |
Primary outcome
The motor portion of the MDS-UPDRS.
Time frame: 9 weeks
The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale. It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).
4 secondary outcomes
Motor function
Time frame: 9 weeks
Static posturography
Time frame: 9 weeks
Walking speed
Time frame: 9 weeks
TUG
Time frame: 9 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 21 May 2025.
- Derived from this study: PubMed 30824206Santos L, Olmo-Aguado SD, Valenzuela PL, Winge K, Iglesias-Soler E, Arguelles-Luis J, Alvarez-Valle S, Parcero-Iglesias GJ, Fernandez-Martinez A, Lucia A. Photobiomodulation in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2019 May-Jun;12(3):810-812. doi: 10.1016/j.brs.2019.02.009. Epub 2019 Feb 20. No abstract available.
- 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.
Luis Santos, PhD principal investigator
Department of Physical Education and Sport (University of León, Spain)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial photobiomodulation in people with Parkinson Disease, run by University of Oviedo at 2 sites in Spain.
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 5 inclusion and 1 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
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?
The motor portion of the MDS-UPDRS. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811613, which also lists 1 linked publication.
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 21 May 2025.