Clinical Trial of Light Therapy for Epilepsy

Epilepsy Clinical Trial

Official title:

A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01028456
• Other study ID #: 09 H0716 68
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 8, 2009
• Last updated: December 8, 2009
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2009
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult

• Medically intractable epilepsy

• Min 4 complex partial seizures/ month

Exclusion Criteria:

• Ability to give informed consent

• Underlying progressive neurological condition

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Light Therapy
10,000 lux / 30 minutes a day
• 100 lux
Placebo light

Locations

Country	Name	City	State
United Kingdom	National Hospital for Neurology & Neurosurgery	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Action Medical Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of seizures/month		3 months	No
Secondary	Mood		3 months	No