Anodal Transcranial Direct Stimulation (tDCS) for the Treatment of Chronic Cluster Headache
NCT ID: NCT02462395
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2014-09-30
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liege
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jean Schoenen
Honorary Full Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Delphine Magis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Liege
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHR Citadelle
Liège, Liege, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANODECCH
Identifier Type: -
Identifier Source: org_study_id