- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028456
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, WC1N 3BG
- National Hospital for Neurology & Neurosurgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult
- Medically intractable epilepsy
- Min 4 complex partial seizures/ month
Exclusion Criteria:
- Ability to give informed consent
- Underlying progressive neurological condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 100 lux
100 lux / 30 minutes day
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Placebo light
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Experimental: Light Therapy 10,000 lux
10,000 lux / 30 minutes a day for 3 months
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10,000 lux / 30 minutes a day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of seizures/month
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mood
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Baxendale S, O'Sullivan J, Heaney D. Bright light therapy for symptoms of anxiety and depression in focal epilepsy: randomised controlled trial. Br J Psychiatry. 2013 May;202(5):352-6. doi: 10.1192/bjp.bp.112.122119. Epub 2013 Mar 21.
- Baxendale S, O'Sullivan J, Heaney D. Bright light therapy as an add on treatment for medically intractable epilepsy. Epilepsy Behav. 2012 Jul;24(3):359-64. doi: 10.1016/j.yebeh.2012.04.123. Epub 2012 May 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09 H0716 68
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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