Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: use of Luminettes ® with active light emission, use of Luminettes ® with a light emission presumed to have no therapeutic effect.
- Who it may be relevant to
- Registry conditions: Cluster Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
Overview
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments. This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache. Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.
Interventions
- Other use of Luminettes ® with active light emission
Spectrum of 400 \< X \< 750 nm assumed active - Other use of Luminettes ® with a light emission presumed to have no therapeutic effect
Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 \< X \< 650 nm assumed to have no therapeutic effect
Primary outcome measures
- The median weekly number of cluster headache attacks [Time frame: At day 28]
Secondary outcome measures (4)
- Incidence and nature of adverse reactions [Time frame: Daily]
- Intensity of cluster headache [Time frame: Daily]
- Use of acute treatments [Time frame: Daily]
- Patient's Global Impression of Change (PGIC) score [Time frame: At day 28]
Eligibility criteria
Inclusion criteria
- Male or female, of 18 years years old or more;
- Diagnosis of chronic cluster headache according to ICHD-3 criteria;
- Number of seizures during baseline equal to at least 24;
- Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
- Patient affiliated to the French social security system.
- Patient who understands and speaks French correctly;
- Patient who has given free and informed written consent.
Exclusion criteria
- Contraindication to the use of light therapy: use of a photosensitizing treatment;
- Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
- Patients who work at night;
- Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
- Background treatment of cluster headache with melatonin;
- Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Hopital La Timone — Marseille
- Hôpital de Cimiez — Nice
Identifiers
NCT: NCT06540651 · RCAPHM23_0463 · 2024-A01453-44