Clinical Trial of Light Therapy for Epilepsy
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Light Therapy
100 lux
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Seizures, Light Therapy
Eligibility Criteria
Inclusion Criteria:
- Adult
- Medically intractable epilepsy
- Min 4 complex partial seizures/ month
Exclusion Criteria:
- Ability to give informed consent
- Underlying progressive neurological condition
Sites / Locations
- National Hospital for Neurology & Neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
100 lux
Light Therapy 10,000 lux
Arm Description
100 lux / 30 minutes day
10,000 lux / 30 minutes a day for 3 months
Outcomes
Primary Outcome Measures
Number of seizures/month
Secondary Outcome Measures
Mood
Full Information
NCT ID
NCT01028456
First Posted
December 8, 2009
Last Updated
December 8, 2009
Sponsor
University College, London
Collaborators
Action Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT01028456
Brief Title
Clinical Trial of Light Therapy for Epilepsy
Official Title
A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University College, London
Collaborators
Action Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizures, Light Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
100 lux
Arm Type
Placebo Comparator
Arm Description
100 lux / 30 minutes day
Arm Title
Light Therapy 10,000 lux
Arm Type
Experimental
Arm Description
10,000 lux / 30 minutes a day for 3 months
Intervention Type
Other
Intervention Name(s)
Light Therapy
Other Intervention Name(s)
Diamond 4 light box
Intervention Description
10,000 lux / 30 minutes a day
Intervention Type
Other
Intervention Name(s)
100 lux
Intervention Description
Placebo light
Primary Outcome Measure Information:
Title
Number of seizures/month
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mood
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
Medically intractable epilepsy
Min 4 complex partial seizures/ month
Exclusion Criteria:
Ability to give informed consent
Underlying progressive neurological condition
Facility Information:
Facility Name
National Hospital for Neurology & Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23520221
Citation
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.
Results Reference
derived
PubMed Identifier
22658437
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Trial of Light Therapy for Epilepsy
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