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Anodal tDCS in Chronic Migraine With Medication Overuse

NCT04336267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-07

No results posted yet for this study

Summary

Non-invasive neuromodulation has been applied in several forms of primary headaches, and its usefulness has been suggested for both episodic and chronic migraine (CM). Transcranial direct current stimulation (tDCS) represents a non-invasive electrical stimulation technique that modulates neural brain activity by means of low amplitude direct current trough surface electrodes.

Very little evidence is available on the potential effect of tDCS in medication overuse and in the management of medication overuse headache (MOH), a condition frequently associated to CM.

CM associated to MOH still represents a challenge for physicians and patients due to the high prevalence in the general population, the associated severe disability, and the high costs imposed by the treatment.

The aim of the study was to investigate the possible application of tDCS in the management of CM associated to MOH. The primary objective of this pilot study was therefore to investigate the efficacy of anodal tDCS delivered on the primary motor cortex (M1) as add-on therapy to an in-hospital detoxification protocol in subjects affected by CM and MOH. The secondary objective was to evaluate the possible changes induced by tDCS on conventional EEG in order to obtain further clues about the effects of tDCS on brain activity.

Conditions

  • Chronic Migraine
  • Medication Overuse Headache

Interventions

DEVICE

Transcranial direct current stimulation (tDCS) group

Patients randomized to the tDCS group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity of anodal stimulation.

DEVICE

Sham group

In the sham group, the stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session.

Sponsors & Collaborators

  • University of Pavia

    collaborator OTHER

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Cristina Tassorelli, MD · IRCCS Mondino Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2017-07-15
Completion
2018-01-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336267 on ClinicalTrials.gov