Photobiomodulation and Parkinson

Parkinson Disease Clinical Trial

Official title:

Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811613
• Other study ID #: #08/18
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: March 30, 2018

Study information

• Verified date: January 2019
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Spain	Department of Physical Education and Sport, University of León	León	Castilla Y León
Spain	University School of Sports Medicine, University of Oviedo, Spain.	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
University of Oviedo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-).	9 weeks
Secondary	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).	9 weeks
Secondary	Walking speed	Ten-meter walk test	9 weeks
Secondary	TUG	Timed up and go test	9 weeks