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

NCT02462395 | Completed Phase 2 DMC

• 1 other identifier: ANODECCH
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Reduction of weekly cluster headache attack frequency during and following tDCS treatment in CCH patients.

  Analysis of the headache diary

  4 to 8 weeks

Secondary Outcomes (5)

• reduction of intensity of CH attacks

  4 to 8 weeks

• reduction of duration of CH attacks

  4 to 8 weeks

• reduction of acute medication intake

  4 to 8 weeks

• modification of the nociceptive blink reflex

  4 to 8 weeks

• modification of pain thresholds

  4 to 8 weeks

Study Arms (1)

Cefaly tDCS

EXPERIMENTAL

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

Interventions

tDCS DEVICE

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.

Also known as: tDCS Cefaly Technology°.

Cefaly tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• No other significant medical or psychiatric disease.

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHR Citadelle

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Delphine Magis, MD

  University of Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Full Professor

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 4, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

BE (1)