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NCT Number: NCT06540651

Efficacy of Light Therapy in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital La Timone, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

use of Luminettes ® with active light emission

Other

Spectrum of 400 < X < 750 nm assumed active

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

Primary outcomes

  1. The median weekly number of cluster headache attacks

    Time frame: 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 outcomes

  1. Incidence and nature of adverse reactions

    Time frame: Daily

    Headache, eye fatigue, dry eyes, nausea

  2. Intensity of cluster headache

    Time frame: Daily

    mild, moderate, severe, very severe

  3. Use of acute treatments

    Time frame: Daily

    sumatriptan and oxygen therapy

  4. Patient's Global Impression of Change (PGIC) score

    Time frame: At day 28

    From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne DONNET

CONTACT

[email protected]

+33491384345

Sophie Tardoski

CONTACT

[email protected]

0491381594 Ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: LUMIAVFc

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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