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Clinical Trial of Light Therapy for Epilepsy
Recruitment status was: Enrolling by invitation
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Purpose
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.
| Condition | Intervention |
|---|---|
| Epilepsy | Other: Light Therapy Other: 100 lux |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy. |
- Number of seizures/month [ Time Frame: 3 months ]
- Mood [ Time Frame: 3 months ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 100 lux
100 lux / 30 minutes day
|
Other: 100 lux
Placebo light
|
|
Experimental: Light Therapy 10,000 lux
10,000 lux / 30 minutes a day for 3 months
|
Other: Light Therapy
10,000 lux / 30 minutes a day
Other Name: Diamond 4 light box
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult
- Medically intractable epilepsy
- Min 4 complex partial seizures/ month
Exclusion Criteria:
- Ability to give informed consent
- Underlying progressive neurological condition
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01028456
| United Kingdom | |
| National Hospital for Neurology & Neurosurgery | |
| London, United Kingdom, WC1N 3BG | |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mr Philip Diamond Senior Research Administrator, UCL |
| ClinicalTrials.gov Identifier: | NCT01028456 History of Changes |
| Other Study ID Numbers: |
09 H0716 68 |
| Study First Received: | December 8, 2009 |
| Last Updated: | December 8, 2009 |
Keywords provided by University College, London:
|
Seizures Light Therapy |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 19, 2017