Using light therapy to treat chronic cluster headaches
Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
NA · Assistance Publique Hopitaux De Marseille · NCT06540651
This study is testing whether light therapy using a special device can help people with chronic cluster headaches feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT06540651 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of light therapy in patients suffering from chronic cluster headaches, a condition that is often challenging to manage. The approach involves using a consumer electronics device, Luminettes®, to deliver light therapy aimed at re-adjusting the chronobiological rhythms associated with this type of headache. Participants will be monitored for the prophylactic effects of this treatment compared to a control group receiving non-therapeutic light emission. The study aims to provide insights into a novel treatment option for this debilitating condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic cluster headache who are stable on their prophylactic treatment.
Not a fit: Patients with contraindications to light therapy or those with certain ophthalmological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, non-invasive option for patients suffering from chronic cluster headaches.
How similar studies have performed: Previous studies have shown light therapy to be effective in treating other chronobiological conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Marseille and 1 other locations
- Hopital La Timone — Marseille, France (RECRUITING)
- Hôpital de Cimiez — Nice, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Anne DONNET
- Email: anne.donnet@ap-hm.fr
- Phone: +33491384345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cluster Headache