Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
  Purpose

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 Intervention
Epilepsy
 Other: Light Therapy
Other: 100 lux

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Clinical Trial of Light Therapy for Medically Intractable Epilepsy.

Resource links provided by NLM:

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

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Number of seizures/month [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University College, London

Additional 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
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University College, London:
Seizures
Light Therapy

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

ClinicalTrials.gov processed this record on March 01, 2015