Clinical Trial of Light Therapy for Epilepsy

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

Action Medical Research

Information provided by:

University College, London

ClinicalTrials.gov Identifier:

NCT01028456

First received: December 8, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 8, 2009
Last Updated Date	December 8, 2009
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 8, 2009)	Number of seizures/month [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 8, 2009)	Mood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of Light Therapy for Epilepsy
Official Title ^ICMJE	A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Epilepsy
Intervention ^ICMJE	Other: Light Therapy 10,000 lux / 30 minutes a day Other Name: Diamond 4 light box Other: 100 lux Placebo light
Study Arm (s)	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
Publications *	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. Epub 2012 May 30.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	September 2011
Estimated Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adult Medically intractable epilepsy Min 4 complex partial seizures/ month Exclusion Criteria: Ability to give informed consent Underlying progressive neurological condition
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01028456
Other Study ID Numbers ^ICMJE	09 H0716 68
Has Data Monitoring Committee	No
Responsible Party	Mr Philip Diamond Senior Research Administrator, UCL
Study Sponsor ^ICMJE	University College, London
Collaborators ^ICMJE	Action Medical Research
Investigators ^ICMJE	Not Provided
Information Provided By	University College, London
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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