Efficacy of Light Therapy in Treatment of Chronic Cluster Headache

Not Applicable

Recruiting

• Conditions: Cluster Headache

• Registration Number: NCT06540651
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-06
• Status Verified: 2025-02
• Study Start: 2025-02-06
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-02-05
• Study Completion: 2027-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The median weekly number of cluster headache attacks	At day 28	The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms.

Secondary Outcome Measures

Name	Time	Method
Incidence and nature of adverse reactions	Daily	Headache, eye fatigue, dry eyes, nausea
Intensity of cluster headache	Daily	mild, moderate, severe, very severe
Use of acute treatments	Daily	sumatriptan and oxygen therapy
Patient's Global Impression of Change (PGIC) score	At day 28	From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated)

Trial Locations

Locations (2)

Hopital La Timone; 🇫🇷 Marseille, France

Hôpital de Cimiez; 🇫🇷 Nice, France