Clinical Trials

Narrow band ultraviolet-B (UVB) light for patients with Clinically Isolated Syndrome

Type of Study/Intervention

Device

Recruitment Status

Closed

Form of MS

Clinically isolated syndrome

Brief summary

People who have experienced for the first time an episode of inflammation within the brain, spinal cord or optic nerves (called a first demyelinating event) are at risk of developing multiple sclerosis (MS). This study will test whether a course of narrow band UVB phototherapy decreases their risk of developing MS.

Patients will be given narrow band (311 nm) UVB light to their full body on 3 occasions per week. Patients will receive a total of 24 administrations over 8 weeks. They will receive the narrow band UVB light as they stand up in a small cubicle. The exposure to the light will range from 1 to 4 minutes each time. A control group will receive no administration of narrow band UVB therapy. A total of 60 patients will be randomly allocated to either receive UVB therapy or no therapy (30 in each group).

Outcome measures will include the effects of phototherapy on immunological function and gene activity of blood cells at six months and the development of a new demyelinating event defined as either (a) a confirmed clinical relapse, or (b) a new cerebral T2 lesion and/or newly Gadolinium-enhancing cerebral lesion as measured in a cerebral MRI.

Brain volume will also be measured by MRI and changes in quality of life, lifestyle and fatigue will also be measured using specialised Questionnaires.

The trial will take place at the St John of God Hospital, Subiaco, WA and is funded by the National Health and Medical Research Council.

Inclusion criteria

Participants may be male or female and must meet the following eligibility criteria:

  • Recently diagnosed (within 120 days) with a first isolated, well-defined, uni- or multi-focal first demyelinating event (FDE);
  • Able to receive their first phototherapy within 120 days of FDE symptom onset;
  • An MRI brain scan that is supportive of demyelinating disease (Paty A or Paty B criteria, i.e. the presence of at least four T2 lesions greater than 3 mm, or at least three T2 lesions greater than 3 mm, one of which must be periventricular, respectively);
  • An Expanded Disability Status Score (EDSS) between 0 – 6.5 (inclusive);
  • Must be able to give informed consent and sign the informed consent form;
  • Must be able to comply with all study procedures, and attend 24 phototherapy sessions and centres for venepuncture on multiple occasions during and after phototherapy;
  • If female of child-bearing age, must be willing to use effective contraception;
  • Must be willing to avoid use of sunbeds;
  • Must be able to stand in the phototherapy cubicle for up to 5 minutes at a time.
  • Aged between 18 and 65 years

Exclusion criteria also apply (for full details view the Australia New Zealand Clinical Trial Registry listing here.

Recruitment contacts

Professor Prue Hart
Telethon Institute for Child Health Research
PO Box 855, West Perth WA 6872
Phone: 08 9489 7887

 

Further details

Full details of the trial can be found on the Australia New Zealand Clinical Trial Registry

 

Region

WA

 

Last updated

March 2018

Contact Us

We're not around right now. But you can send us an email and we'll get back to you, asap.

Start typing and press Enter to search