Evaluating the safety and feasibility of the application of transcranial photobiomodulation therapy for the clinical signs and quality of life of Parkinson's disease patients

Not Applicable

Completed

• Conditions: Parkinson's disease; Neurological - Parkinson's disease

• Registration Number: ACTRN12621001722886
• Lead Sponsor: SYMBYX Biome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-16
• Study Completion: 2022-08-12
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Females and males diagnosed with Idiopathic Parkinson's disease (by UK Brain Bank Criteria) with Modified Hoen & Yahr staging of I - III during ON periods, and with 3 or more weeks of stable anti-Parkinson's disease medication.
Sufficient space at home (around 9 m2) to be able to perform motor assessments; Stable and sufficiently fast home-based internet connection for uninterrupted video calls and video conferencing; Knowledge (self or carer) of using a phone and/or tablet applications on either IOS or Android platforms

Exclusion Criteria

Participants with the following will be excluded from the study, if they: are incapable of self-care; have cognitive impairment with a MoCa score of <24; history of significant psychotic episode(s) within the last 12-months; history of suicidal ideation or attempted suicide within the last 12-months; take potentially photosensitising medication, especially imipramine, hypericum, phenothiazine, lithium, chloroquine, hydrochlorothiazide, or tetracycline; have a history of structural brain disease, active epilepsy, stroke or acute illness, factors affecting gait performance and stance such as severe joint disease, orthopaedic injuries, weakness, peripheral neuropathy with proprioceptive deficits, severe peripheral vascular occlusive disease, severe musculoskeletal disorders, uncorrected vision, vestibular problems or other severe conditions (such as those that preclude the use of photobiomodulation therapy, that places the patient at risk during evaluation of their Parkinson's disease, or interferes with the evaluation of their Parkinson's disease); have cardiac disease; are currently participating other trials regarding the treatment of Parkinson's disease, such as advanced therapies (including Duodopa, Apomorphine, Deep Brain Stimulation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified