Chronic Migraine Clinical Trial
Official title:
Anodal Transcranial Direct Current Stimulation in Chronic Migraine With and Medication Overuse Headache: a Pilot Randomized Sham-controlled Trial
Verified date | March 2020 |
Source | IRCCS National Neurological Institute "C. Mondino" Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 15, 2018 |
Est. primary completion date | July 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age 18 to 65 years; - chronic migraine according to the criteria of the InternationaI Classification of Headache Disorders (code 1.3 ICHD-III) and Medication Overuse Headache (code 8.2 ICHD-III) present for at least 6 months at inclusion; - previous failure of at least three prophylactic treatments. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
IRCCS National Neurological Institute "C. Mondino" Foundation | University of Pavia |
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Migraine Disability Assessment (MIDAS) | Migraine related disability measured by the MIDAS. MIDAS test: 0-5 (grade I): minimal disability, 6-10 (grade II): mild disability, 11-20 (grade III): moderate disability, 21-40 (grade IVa): severe disability, 41 and higher (grade IVb): very severe disability. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Headache Impact Test-6 (HIT-6). | Migraine related disability measured by the HIT-6. A score of 49 or less: no impact, 50-55: some impact, 56-59: substantial impact, 60-78 severe impact. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Visual Analogue Scale (VAS) | Migraine related disability measured by VAS for pain intensity. VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Migraine-Specific Quality-of-Life Questionnaire (MSQ) | Migraine related disability measured by MSQ. It is a 14-item assessment, with each item rated on a 6-point scale (ranging from "none of the time" to "all of the time"). The investigators evaluated 3 scores, namely Role Function-Restrictive (RR), Role Function- Preventive (RP), and Emotional Function (EF). Raw scores have been transformed to a 100-point scale, with higher scores indicating better quality of life. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Short Form Health Survey (SF-36). | Migraine related disability measured by SF-36.It gives information about 8 different domains: physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Sleep Condition Indicator (SCI) | Sleep quality measured by SCI. It is a 8-item questionnaire, with a score that range from 0 to 32. A higher score points toward a better sleep, while a score below 16 is significant for insomnia disorders. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Sleep quality measured by PSQI. The questionnaire differentiates "poor" from "good" sleepers. A global score greater than five indicates poor sleep quality, with a maximum score of 21 (the worst overall sleep). | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Zung scale for anxiety | Psychological aspects measured by the Zung scale for anxiety. It is a 20-item questionnaire, with a score that range from 20 to 80. A score above 36 is clinically significant for the presence of anxiety. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | Zung scale for depression | Psychological aspects measured by the Zung scale for depression. It is a 20-item questionnaire with a score that range from 20 to 80. A score above 40 is clinically significant for the presence of depression. | Baseline (T0), after 1 month from hospital discharge (T2) | |
Secondary | EEG power spectrum (µV2) of alpha frequencies | For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. Epochs with eye movements, artifacts or periods of drowsiness were excluded from analysis. Power spectral density was calculated on the whole track, using a time windows of 5 seconds, with an overlapping of the samples equal to 50% and introducing zeropadding to reach a resolution of 0.1 Hz. | Percentage modification of EEG power spectrum of alpha frequencies from T0 (baseline) to T2 (1 month after hospital discharge) | |
Secondary | EEG power spectrum (µV2) of beta frequencies | For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. Epochs with eye movements, artifacts or periods of drowsiness were excluded from analysis. Power spectral density was calculated on the whole track, using a time windows of 5 seconds, with an overlapping of the samples equal to 50% and introducing zeropadding to reach a resolution of 0.1 Hz. | Percentage modification of EEG power spectrum of beta frequencies from T0 (baseline) to T2 (1 month after hospital discharge) | |
Secondary | EEG power spectrum (µV2) of theta frequencies | For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. Epochs with eye movements, artifacts or periods of drowsiness were excluded from analysis. Power spectral density was calculated on the whole track, using a time windows of 5 seconds, with an overlapping of the samples equal to 50% and introducing zeropadding to reach a resolution of 0.1 Hz. | Percentage modification of EEG power spectrum of theta frequencies from T0 (baseline) to T2 (1 month after hospital discharge) | |
Secondary | EEG power spectrum (µV2) of delta frequencies | For the EEG signal analysis, the investigators used a spectral analysis through a fast Fourier transformation. Epochs with eye movements, artifacts or periods of drowsiness were excluded from analysis. Power spectral density was calculated on the whole track, using a time windows of 5 seconds, with an overlapping of the samples equal to 50% and introducing zeropadding to reach a resolution of 0.1 Hz. | Percentage modification of EEG power spectrum of delta frequencies from T0 (baseline) to T2 (1 month after hospital discharge) |
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