Photobiomodulation and Parkinson

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Transcranial photobiomodulation

• Registration Number: NCT03811613
• Lead Sponsor: University of Oviedo

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).

Study Timeline

• Study Start: 2018-01-29
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-18
• Last Update Submitted: 2019-01-18
• Study First Posted: 2019-01-22
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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Exclusion Criteria

• Do not follow inclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation group	Transcranial photobiomodulation	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.
Sham group	Transcranial photobiomodulation	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).

Primary Outcome Measures

Name	Time	Method
The motor portion of the MDS-UPDRS.	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-).

Secondary Outcome Measures

Name	Time	Method
Motor function	9 weeks	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	9 weeks	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	9 weeks	Ten-meter walk test
TUG	9 weeks	Timed up and go test

Trial Locations

Locations (2)

University School of Sports Medicine, University of Oviedo, Spain.; 🇪🇸 Oviedo, Asturias, Spain

Department of Physical Education and Sport, University of León; 🇪🇸 León, Castilla Y León, Spain