Anodal tDCS in Chronic Migraine With Medication Overuse

NCT04336267 | Completed FDA Device

• 1 other identifier: tDCS-CM
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Neuromodulation; Transcranial direct current stimulation; Chronic migraine; Medication overuse headache; EEG

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  Headache frequency measured by number of migraine days per month recorded in a headache diary.

  Change in number of migraine days from T0 (baseline) to T2 (1 month after hospital discharge)

Secondary Outcomes (13)

• Migraine Disability Assessment (MIDAS)

  Baseline (T0), after 1 month from hospital discharge (T2)

• Headache Impact Test-6 (HIT-6).

  Baseline (T0), after 1 month from hospital discharge (T2)

• Visual Analogue Scale (VAS)

  Baseline (T0), after 1 month from hospital discharge (T2)

• Migraine-Specific Quality-of-Life Questionnaire (MSQ)

  Baseline (T0), after 1 month from hospital discharge (T2)

• Short Form Health Survey (SF-36).

  Baseline (T0), after 1 month from hospital discharge (T2)

Study Arms (2)

Transcranial direct current stimulation (tDCS) group

EXPERIMENTAL

7-day detoxification protocol + 5 consecutive days of anodal tDCS treatment over the primary motor cortex.

Device: Transcranial direct current stimulation (tDCS) group

Sham group

SHAM COMPARATOR

7-day detoxification protocol + 5 consecutive days of sham treatment over the primary motor cortex.

Device: Sham group

Interventions

Transcranial direct current stimulation (tDCS) group DEVICE

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.

Transcranial direct current stimulation (tDCS) group

Sham group DEVICE

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.

Sham group

Eligibility Criteria

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

You may qualify if:

• age 18 to 65 years;
• previous failure of at least three prophylactic treatments.

You may not qualify if:

• other neurologic or neuropsychiatric diseases;
• other chronic painful syndromes;
• other types of primary or secondary headaches;
• use of a preventive medication at baseline;
• use of central nervous system modulating drugs;
• epilepsy;
• metallic head implants or use of a cardiac pacemaker;
• pregnancy or lactation.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• University of Pavia: collaborator

Related Publications (25)

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MeSH Terms

Conditions

Headache Disorders, Secondary

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

• Cristina Tassorelli, MD

  IRCCS Mondino Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Transcranial direct current stimulation (tDCS) was delivered by a technician that was not otherwise involved in the management of patients. The managing physician and the patient were instead blind to the type of stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized sham-controlled trial

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 7, 2020
• Study Start: January 15, 2015
• Primary Completion: July 15, 2017
• Study Completion: January 15, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share