Anodal Transcranial Direct Stimulation (tDCS) for the Treatment of Chronic Cluster Headache
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): tDCS Cefaly Technology°.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment