Health TrialsbyHealthPanel

Efficacy of Light Therapy in Treatment of Chronic Cluster Headache

ConditionCluster Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • use of Luminettes ® with active light emission

    Other intervention

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

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

    Other intervention

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Experimental group (group 1)Experimental treatment 1 intervention
Group B: Control group (group 2)Placebo comparator 1 intervention

Trial outcomes

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.

Time frame
At day 28

Secondary outcomes

1

Incidence and nature of adverse reactions

Headache, eye fatigue, dry eyes, nausea

Time frame
Daily
2

Intensity of cluster headache

mild, moderate, severe, very severe

Time frame
Daily
3

Use of acute treatments

sumatriptan and oxygen therapy

Time frame
Daily
4

Patient's Global Impression of Change (PGIC) score

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

Time frame
At day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov
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