arrow band ultraviolet B (UVB) phototherapy in amyotrophic lateral sclerosis

Phase 2

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Neurological - Neurodegenerative diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12615000802505
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Possible, probable or definite sporadic or familial ALS using the Awaji criteria (de Carvahlo et al, 2008, Clin neurophysiol, 119: 497-503).
2. Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) of greater than or equal to 38.
3. Ability to comply with all study procedures including standing in the treatment cubicle, attending 36 phototherapy visits, blood collection, and clinical assessments.

Exclusion Criteria

1. ALS symptoms, other cardiovascular/ respiratory disease or any condition that prevents standing in the enclosed treatment cubicle for up to 10 min.
2. Any immunological conditions including autoimmunity or other inflammatory conditions, or immunosuppressive or immunomodulatory medication that may independently influence regulatory T cell numbers.
3. Pregnancy or planning to become pregnant, as this alters regulatory T cell numbers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified