arrow band ultraviolet-B (UVB) light for patients with Clinically Isolated Syndrome
- Conditions
- Clinically Isolated SyndromeMultiple SclerosisNeurological - Multiple sclerosis
- Registration Number
- ACTRN12614000185662
- Lead Sponsor
- niversity of Western Australia
- Brief Summary
As preclinical studies have suggested that exposure to ultraviolet radiation could reduce the development of MS, the Phototherapy for CIS (PhoCIS) trial was established to examine the effect of narrowband UVB phototherapy on patients with Clinically Isolated Syndrome (CIS), and their conversion to MS. By 12 months, 100% of those in the no phototherapy arm and 70% in the phototherapy arm had converted to MS. This difference was not statistically significant but provides the basis for further studies of narrowband UVB irradiation on MS progression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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 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
Known co-morbid illnesses that might be exacerbated by phototherapy, including lupus erythematosus and xeroderma pigmentosum
A history of melanoma, multiple non melanoma skin cancers
Previous prolonged courses of UVB or photochemotherapy (PUVA), or use of sunbeds
Cardiovascular or respiratory disease that would prevent standing in the treatment cubicle
Bullous disease
Use of photosensitizing medications
Very fair skin that burns with very minimal sun exposure (as judged by the dermatologist involved)
Corticosteroids within 3 months, or current immunosuppressive drug therapy (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, or other chemotherapy agent specifically for demyelinating disease) prior to CIS diagnosis. (*Note that requirement for immunomodulatory therapy in the course of MS disease management will not exclude patients during follow-up; treatment variables will be collected and analysed in both the intervention and control arms in the planned analysis).
Current pregnancy, breastfeeding or planning to become pregnant in the next 12 months.
A second clinical demyelinating event prior to randomisation
Concurrent diagnosis of other neurological, psychiatric or other disease, which, in the opinion of the investigator, could impair capacity to provide informed consent or interfere with study compliance.
Current enrolment in another interventional trial
Any contraindication to MRI scanning or intravenous Gadolinium including: Cardiac Pacemaker, Cardiac Defibrillator, Metal fragments in the eye, Any other non-MRI compatible medical device/implant or medical condition, Previous allergic reaction to Gadolinium, Severe claustrophobia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phototherapy-associated changes in the mRNA transcripts and properties of cells in freshly isolated peripheral blood.<br><br>The types of cells in freshly isolated blood, the mRNA levels in these cells, and the immunological function of blood cells will be assessed by standard laboratory protocols[6 month measurement compared to baseline];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.<br><br>[12 month measurement compared to baseline MRI scan]
- Secondary Outcome Measures
Name Time Method Phototherapy-associated changes in quality of life measures for the participants with Clinically Isolated Syndrome.<br><br>This will be measured by Questionnaires (SF36v2, specially designed lifestyle questionnaires, Fatigue Severity Table)[12 month measurement compared to baseline measurement];Cerebral MRI volume changes.[12 month measurement compared to baseline measurement]