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Clinical Trial of Light Therapy for Epilepsy

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.
ClinicalTrials.gov Identifier: NCT01028456
Recruitment Status : Unknown
Verified December 2009 by University College, London.
Recruitment status was:  Enrolling by invitation
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment
Epilepsy Other: Light Therapy Other: 100 lux

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.
Study Start Date : September 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of seizures/month [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Mood [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028456


Locations
United Kingdom
National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Action Medical Research
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
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by University College, London:
Seizures
Light Therapy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases