Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02122237
Other study ID # CB-1289
Secondary ID
Status Completed
Phase Phase 3
First received November 4, 2013
Last updated May 27, 2015
Start date September 2013
Est. completion date September 2014

Study information

Verified date May 2015
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.


Description:

During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.

In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date September 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

- others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cefaly tDCS
Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.

Locations

Country Name City State
Belgium Roberta Baschi Liège

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Migraine frequency The investigators evaluate migraine frequency at baseline, during the treatment and 2 months after its end. 6 months
Secondary Migraine intensity The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end. 6 months
Secondary Acute medication intake The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end. 6 months
Secondary Attack duration The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end. 6 months
Secondary Scores at psychological scales The investigators evaluate scores at psychological scales at baseline, during the treatment and 2 months after its end. 6 months
See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Completed NCT02514148 - Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients N/A
Enrolling by invitation NCT02291380 - A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine Phase 3
Withdrawn NCT02122744 - RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine N/A
Recruiting NCT02202486 - Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI N/A
Completed NCT01709708 - Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine Phase 4
Completed NCT01741246 - Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging N/A
Completed NCT01090050 - Treximet in the Treatment of Chronic Migraine Phase 4
Recruiting NCT03507400 - Introvision for Migraine and Headaches N/A
Completed NCT04161807 - Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine N/A
Completed NCT03175263 - OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain N/A
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Completed NCT01700387 - A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency Phase 4
Completed NCT01667250 - Non-Invasive Neurostimulation for the Prevention of Chronic Migraine N/A
Not yet recruiting NCT01135784 - Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache Phase 2
Completed NCT01496950 - Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine Phase 1
Completed NCT00772031 - NINDS CRC Chronic Migraine Treatment Trial Phase 3