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Clinical Trial of Light Therapy for Epilepsy

NCT ID: NCT01028456

Last Updated: 2009-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Epilepsy

Keywords

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Seizures Light Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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100 lux

100 lux / 30 minutes day

Group Type PLACEBO_COMPARATOR

100 lux

Intervention Type OTHER

Placebo light

Light Therapy 10,000 lux

10,000 lux / 30 minutes a day for 3 months

Group Type EXPERIMENTAL

Light Therapy

Intervention Type OTHER

10,000 lux / 30 minutes a day

Interventions

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Light Therapy

10,000 lux / 30 minutes a day

Intervention Type OTHER

100 lux

Placebo light

Intervention Type OTHER

Other Intervention Names

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Diamond 4 light box

Eligibility Criteria

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Inclusion Criteria

* Adult
* Medically intractable epilepsy
* Min 4 complex partial seizures/ month

Exclusion Criteria

* Ability to give informed consent
* Underlying progressive neurological condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Action Medical Research

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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UCL

Locations

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National Hospital for Neurology & Neurosurgery

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23520221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22658437 (View on PubMed)

Other Identifiers

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09 H0716 68

Identifier Type: -

Identifier Source: org_study_id