Efficacy of Light Therapy in Treatment of Chronic Cluster Headache (LUMIAVFc)

Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Cluster Headache
• Intervention / Treatment: Other: use of Luminettes ® with active light emission; Other: use of Luminettes ® with a light emission presumed to have no therapeutic effect

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Donnet; Phone Number: +33491384345; Email: anne.donnet@ap-hm.fr
• Study Contact Backup: Name: Sophie Tardoski; Phone Number: 0491381594 Ext. 33; Email: sophie.tardoski@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Hôpital la Timone
    • Contact: Anne Donnet; Phone Number: +33491384345; Email: anne.donnet@ap-hm.fr
  • Nice, France, 06000
    • Not yet recruiting
    • Hôpital de Cimiez
    • Contact: Michel LANTERI-MINET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (group 1); Luminette® with active light emission in the 400 < X < 750 nm spectrum	Other: use of Luminettes ® with active light emission; Spectrum of 400 < X < 750 nm assumed active
Placebo Comparator: Control group (group 2); Luminette ® with modified spectral parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect (placebo effect)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The median weekly number of cluster headache attacks	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.	At day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): May 5, 2027

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: RCAPHM23_0463; 2024-A01453-44 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No