NCT03811613

Brief Summary

This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
Last Updated

May 21, 2025

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 15, 2019

Last Update Submit

May 16, 2025

Conditions

Parkinson Disease

Keywords

movement disorderslight therapymotor aspects

Outcome Measures

Primary Outcomes (1)

  • 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-).

    9 weeks

Secondary Outcomes (4)

  • Motor function

    9 weeks

  • Static posturography

    9 weeks

  • Walking speed

    9 weeks

  • TUG

    9 weeks

Study Arms (2)

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.

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).

Other: Transcranial photobiomodulation

Interventions

Transcranial photobiomodulationOTHER

Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)

Also known as: LEDs
Photobiomodulation groupSham group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Physical Education and Sport, University of León

León, Castille and León, 24071, Spain

Location

University School of Sports Medicine, University of Oviedo, Spain.

Oviedo, Principality of Asturias, 33005, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30824206DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMovement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Luis Santos, PhD

    Department of Physical Education and Sport (University of León, Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 22, 2019

Study Start

January 29, 2018

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

May 21, 2025

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)