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Anodal Transcranial Direct Stimulation (tDCS) for the Treatment of Chronic Cluster Headache (ANODECCH)

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ClinicalTrials.gov Identifier: NCT02462395
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jean Schoenen, University of Liege

Brief Summary:

Cluster headache is a primary headache that chiefly affects young men, and is less common than migraine. This disease can have devastating consequences due to the pain intensity (it is also called "suicide headache"), to the side effects of the drug preventive therapies, and to the resistance of some subtypes of the headache to all existing medications.

Recent studies suggest that cluster headache could be associated with a decrease of the activity of frontal areas involved in descending pain control, in particular the subgenual anterior cingulate cortex. The aim of this pilot study is to activate these areas with a non-invasive neurostimulation technique, called transcranial direct current stimulation, as a preventive treatment for cluster headache sufferers.


Condition or disease Intervention/treatment Phase
Chronic Cluster Headache Device: tDCS Phase 2 Phase 3

Detailed Description:

Cluster headache affects 0.1%-0.25% of the general population, but its prevalence may be underestimated. It is a primary headache disorder with a higher prevalence in young males, characterized by attacks of severe unilateral periorbital/temporal pain with autonomic symptoms (ie lacrimation, nasal congestion, eyelid edema, Horner's…) and agitation, lasting 15 to 180 minutes and occurring periodically in bouts (clusters) in about 90% of patients (episodic cluster headache or ECH, ICHD-III criteria 3.1.1).In 10% of patients there is no sustained spontaneous remission for long periods, which defines chronic cluster headache (CCH, ICHD-III criteria 3.1.2).

The pathophysiology of cluster headache is not completely understood, but neuroimaging studies clearly suggest that activation of the ipsilateral postero-ventral hypothalamus plays a seminal role during the attack. Recent findings suggest that prefrontal areas may be dysfunctioning in cluster headache patients. The investigator shave shown in CCH patients that the beneficial effects of ONS are associated with activation of the subgenual anterior cingulate cortex, an area responsible for descending pain-control. Transcranial direct current stimulation (tDCS) allows activating the underlying cortex and connected subcortical structures under the anode or inhibiting them under the cathode. tDCS was used as a therapeutic strategy in various neurological disorders, chronic pain disorders and depression. Because of its non-invasiveness, It is of particular interest in primary headaches where various brain areas are known to function abnormally even between headache attacks. It has been tested in migraine but not in cluster headache.

In a recent study, the investigators have shown that anodal tDCS over the visual cortex is able to modify visual evoked potentials in healthy volunteers and migraineurs, and after a 2-month treatment of 2 weekly sessions to significantly decrease attack frequency in episodic migraine.

CCH patients will have to apply the neurostimulation outside of an attack every day for 20 minutes during 4 to 8 weeks.

Adherence to the treatment will be evaluated by monitoring the time during which the device is switched on via an in-built software.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anodal Transcranial Direct Stimulation (tDCS) of the Anterior Cingulate Gyrus for the Treatment of Chronic Cluster Headache: a Pilot Trial.
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Cefaly tDCS
Sponge-electrodes (5 x 7 cm) will be postioned at Fz (anode) and over the spinous process of C7 (cathode). Stimulation intensity will be set to 2 mA.
Device: tDCS

Sponge-electrodes (5 x 7 cm) will be postioned at Fz (anode) and over the spinous process of C7 (cathode). Stimulation intensity will be set to 2 mA.

A first group of CCH patients will have to apply the neurostimulation outside of an attack every day for 20 minutes during 4 weeks. A second group will use the tDCS device everyday for 8 weeks.

Adherence to the treatment will be evaluated by monitoring the time during which the device is switched on via an in-built software.

Other Name: tDCS Cefaly Technology°.




Primary Outcome Measures :
  1. Reduction of weekly cluster headache attack frequency during and following tDCS treatment in CCH patients. [ Time Frame: 4 to 8 weeks ]
    Analysis of the headache diary


Secondary Outcome Measures :
  1. reduction of intensity of CH attacks [ Time Frame: 4 to 8 weeks ]
    Analysis of the headache diary

  2. reduction of duration of CH attacks [ Time Frame: 4 to 8 weeks ]
    Analysis of the headache diary

  3. reduction of acute medication intake [ Time Frame: 4 to 8 weeks ]
    Analysis of the headache diary

  4. modification of the nociceptive blink reflex [ Time Frame: 4 to 8 weeks ]
  5. modification of pain thresholds [ Time Frame: 4 to 8 weeks ]
    using quantitative sensory testing



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main inclusion criteria for CCH: preventive CH therapy stable for a least 2 months, retrospective 4-week headache baseline diary showing at least 4 attacks/week on average

Exclusion Criteria:

  • No other significant medical or psychiatric disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462395


Locations
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Belgium
CHR Citadelle
Liege, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Delphine Magis, MD University of Liege

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Responsible Party: Jean Schoenen, Honorary Full Professor, University of Liege
ClinicalTrials.gov Identifier: NCT02462395     History of Changes
Other Study ID Numbers: ANODECCH
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases