Back to resultsPhotobiomodulation and Parkinson
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcranial photobiomodulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring movement disorders, light therapy, motor aspects
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Do not follow inclusion criteria.
Sites / Locations
- University School of Sports Medicine, University of Oviedo, Spain.
- Department of Physical Education and Sport, University of León
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Photobiomodulation group
Sham group
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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-).
Secondary Outcome Measures
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-).
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).
Walking speed
Ten-meter walk test
TUG
Timed up and go test
Full Information
NCT ID
NCT03811613
First Posted
January 15, 2019
Last Updated
January 18, 2019
Sponsor
University of Oviedo
1. Study Identification
Unique Protocol Identification Number
NCT03811613
Brief Title
Photobiomodulation and Parkinson
Official Title
Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
movement disorders, light therapy, motor aspects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Transcranial photobiomodulation
Other Intervention Name(s)
LEDs
Intervention Description
Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
Primary Outcome Measure Information:
Title
The motor portion of the MDS-UPDRS.
Description
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-).
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Motor function
Description
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-).
Time Frame
9 weeks
Title
Static posturography
Description
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).
Time Frame
9 weeks
Title
Walking speed
Description
Ten-meter walk test
Time Frame
9 weeks
Title
TUG
Description
Timed up and go test
Time Frame
9 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Do not follow inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Santos, PhD
Organizational Affiliation
Department of Physical Education and Sport (University of León, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University School of Sports Medicine, University of Oviedo, Spain.
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33005
Country
Spain
Facility Name
Department of Physical Education and Sport, University of León
City
León
State/Province
Castilla Y León
ZIP/Postal Code
24071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30824206
Citation
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.
Results Reference
derived
Learn more about this trial
Photobiomodulation and Parkinson
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