Efficacy of Light Therapy in Treatment of Chronic Cluster Headache

NCT06540651 | Recruiting DMC

• 2 other identifiers: RCAPHM23_04632024-A01453-44
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence and nature of adverse reactions

  Daily

• Intensity of cluster headache

  Daily

• Use of acute treatments

  Daily

• Patient's Global Impression of Change (PGIC) score

  At day 28

Study Arms (2)

Experimental group (group 1)

EXPERIMENTAL

Luminette® with active light emission in the 400 \< X \< 750 nm spectrum

Other: use of Luminettes ® with active light emission

Control group (group 2)

PLACEBO COMPARATOR

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

Interventions

use of Luminettes ® with active light emission OTHER

Spectrum of 400 \< X \< 750 nm assumed active

Experimental group (group 1)

use of Luminettes ® with a light emission presumed to have no therapeutic effect OTHER

Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 \< X \< 650 nm assumed to have no therapeutic effect

Control group (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (2)

Hopital La Timone

Marseille, 13005, France

RECRUITING

Hôpital de Cimiez

Nice, 06000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anne DONNET

CONTACT

+33491384345; anne.donnet@ap-hm.fr

Sophie Tardoski

CONTACT

0491381594 Ext. 33; sophie.tardoski@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)