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Clinical Trial of Light Therapy for Epilepsy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by University College, London.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028456
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Action Medical Research
Information provided by:
University College, London
December 8, 2009
December 9, 2009
December 9, 2009
September 2010
April 2011   (Final data collection date for primary outcome measure)
Number of seizures/month [ Time Frame: 3 months ]
Same as current
No Changes Posted
Mood [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Clinical Trial of Light Therapy for Epilepsy
A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.

This study is designed to investigate whether light therapy may be an effective treatment for some people with epilepsy. Light treatment is already an established treatment for depression. The chemical systems in the brain that are disrupted when someone becomes depressed, overlap with some of those that can be affected during some epileptic seizures. The investigators have designed this study to see whether light therapy may also lead to a decrease in seizures in people who have epilepsy.

The study will be a placebo controlled trial. This means that half of the participants will receive a therapeutic dose of light therapy from a light box, whilst the other half will only receive a placebo light treatment.

The aim of this study is to investigate a new, non invasive treatment for epilepsy that may be useful as an adjunctive therapy for people whose seizures are poorly controlled with anti epileptic drugs. Light therapy is a well established treatment for some forms of depression. From the cellular level to epidemiological studies, there are numerous strands of evidence in the scientific literature that indicate that light therapy could be also an effective treatment for some people with epilepsy.

The proposed study is a randomised placebo controlled trial of light therapy. One hundred people with medically refractory epilepsy will be recruited. Participants will be randomised to receive either therapeutic or placebo doses of light therapy from an identical device for 30 minutes a day during the treatment phase of the study. The statistical power of this study design is >90% to detect a 25% reduction in seizure frequency during the treatment phase. Although this therapeutic approach is more likely to be palliative than curative, it represents a non invasive and relatively inexpensive add-on treatment option for a sub group of patients who may have reached the end of the road in other medical and surgical treatment options.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsy
  • Other: Light Therapy
    10,000 lux / 30 minutes a day
    Other Name: Diamond 4 light box
  • Other: 100 lux
    Placebo light
  • Placebo Comparator: 100 lux
    100 lux / 30 minutes day
    Intervention: Other: 100 lux
  • Experimental: Light Therapy 10,000 lux
    10,000 lux / 30 minutes a day for 3 months
    Intervention: Other: Light Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
September 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult
  • Medically intractable epilepsy
  • Min 4 complex partial seizures/ month

Exclusion Criteria:

  • Ability to give informed consent
  • Underlying progressive neurological condition
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01028456
09 H0716 68
No
Not Provided
Not Provided
Mr Philip Diamond Senior Research Administrator, UCL
University College, London
Action Medical Research
Not Provided
University College, London
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP