NCT01028456

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

Enrollment Period

7 months

First QC Date

December 8, 2009

Last Update Submit

December 8, 2009

Conditions

Keywords

SeizuresLight Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of seizures/month

    3 months

Secondary Outcomes (1)

  • Mood

    3 months

Study Arms (2)

100 lux

PLACEBO COMPARATOR

100 lux / 30 minutes day

Other: 100 lux

Light Therapy 10,000 lux

EXPERIMENTAL

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

Other: Light Therapy

Interventions

10,000 lux / 30 minutes a day

Also known as: Diamond 4 light box
Light Therapy 10,000 lux
100 luxOTHER

Placebo light

100 lux

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Ability to give informed consent
  • Underlying progressive neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital for Neurology & Neurosurgery

London, London, WC1N 3BG, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

EpilepsySeizures

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations