Light Therapy as Treatment for Fatigue in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      This prospective study will randomize 1:1 people living with multiple sclerosis-associated
      fatigue to one of two spectra of light therapy. Each participant will be asked to use the
      light box twice daily at home or at the workplace at preset hours during the day for a total
      of four weeks. Participants will be asked to record their fatigue on standard measurement
      scales before, during, and after the use of the light therapy box. The investigators
      anticipate a reduction in self-reported fatigue following the use of the light box therapy of
      a particular spectrum of light among people living with multiple sclerosis.
    

Detailed description: 
      Study Protocol:

      Eligible participants will be consented and randomized 1:1 to (a) white LT (10,000 lux), or
      (b) dim red LT (<300 lux). Participants will be informed that this study will examine the
      effect of two different light spectra on fatigue. The following assessments will be
      administered by the study principal investigator at the baseline visit: (1) the Kurtzke
      Extended Disability Status Scale (EDSS), (2) FSS, (3) Beck Depression Inventory II (BDI), (4)
      Pittsburgh Sleep Quality Index (PSQI), (5) Berlin questionnaire for obstructive sleep apnea,
      (6) Epworth Sleepiness Scale. A two-week sleep diary will be collected before enrollment in
      order to screen for significant behavioral insufficient sleep or circadian rhythm disorders.
      The light box used for LT is designed to stand on a desk or tabletop. It can be used in the
      home or office. The light is delivered at a downward angle to maximize the effectiveness. The
      box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs. Bright light
      treatment requires at least 2,500 lux to be effective.

      Data Collection:

      The study period will include a two-week baseline period, a four-week treatment period, and a
      four-week follow up period. Throughout the study period, participants will record their
      fatigue using the Visual Analogue Fatigue Scale (VAFS) four times daily, starting after
      waking up, and every four hours thereafter. The VAFS is a simple, validated 10-point scale
      ranging from 1 to 10 in which participants can report their fatigue as a snapshot at that
      particular moment. Data collection will occur by participants in self-report fashion. A FSS
      score will be collected at enrollment as well as at the end of the four week treatment period
      and the end of the four week follow-up period. There will be three visits with a principal
      investigators (PI), including the baseline visit described above, a visit with the PI at the
      end of the treatment period in which participants will report a FSS and discuss their
      experiences with LT, and a third follow-up visit at the end of the four-week follow up period
      for a final FSS. At this last visit they will be queried on whether they believe the
      intervention had any effect on their fatigue and whether they believe the alternative therapy
      (white light or dim red light) would have been more or less beneficial. Additionally
      participants will be asked to keep a LT log in which they will record daily LT exposure and
      associated side effects.

      Statistical Analysis:

      The primary outcome measure is the change in the average FSS after the four-week study period
      in the bright light "active" vs. dim light "control" groups. There are no reports on FSS in
      response to bright LT in pMS. Using the conventional values of α=0.05 and β=0.80 for 2-tailed
      tests of probability with equally sized groups: a difference in 10 points on FSS between
      groups requires 18 people per study arm; a difference in 8 points requires 28 people per
      group. If power is reduced to 70%, the sample sizes are 22 and 14 for 8-point and 10-point
      differences. First, the investigators will compare the mean change in FSS scores, from
      baseline to after completion of LT, in an intention to treat analysis. The secondary outcome
      measure will be a change in the global VAFS scores after light therapy in both groups.
      Frequencies will be used to describe baseline characteristics across treatment arms. X2
      statistics or Fisher's exact test will be used to compare the differences between groups.
      VAFS will be evaluated using a mixed-effects model which accounts for correlation between
      repeated measurements. Participant logbooks will be used to generate summary statistics and
      graphically display fatigue patterns throughout the day. Logbooks will also qualitatively
      assess the safety and tolerability of LT.
    

Intervention name(s): Light Therapy box
Intervention type(s): Device
Intervention description(s): The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5" tall x 23" wide x 3.25" deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Fatigue; Light Therapy