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New treatment option for Chronic Migraine
Official title Study on 30 Outpatients With Chronic Migraine Treated With Well-Being Therapy or With a Control Therapy
ClinicalTrials.gov ID: NCT03404336
What this study is testing
- What it's testing
- Chronic migraine is a disabling type of migraine and is often resistant to treatment. Non-pharmacological interventions have been investigated as potential treatment although, unfortunately, the literature on their efficacy is poor and showed mixed results.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- able and interested in participating to the present research project, as proved by signed Informed consent;
- 18-65 years of age;
- Italian mother tongue;
- diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e...
- headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;
You likely can't join if
- diagnosis of medication overuse headache;
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via...
- co-occurrence of chronic unstable medical conditions;
- being pregnant or lactating;
- under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
See the full eligibility criteria
- able and interested in participating to the present research project, as proved by signed Informed consent;
- 18-65 years of age;
- Italian mother tongue;
- diagnosis of chronic migraine according to the International Classification of Headache Disorders. Thus, presenting specific features (i.e., unilateral and pulsating pain of moderate or severe intensity, which is...
- headache chronicity for a minimum of 1 year and pattern of headache symptoms stable for a period of at least 6 months;
- no pharmacological therapy or dietary supplements use for chronic migraine OR pharmacological therapy/dietary supplement use for chronic migraine stable since at least 3 months;
- psychotropic medication allowed only if stable since at least three months.
- diagnosis of medication overuse headache;
- co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders (DSM) 5th edition as diagnosed via the MINI International Neuropsychiatric Interview;
- co-occurrence of chronic unstable medical conditions;
- being pregnant or lactating;
- under exogeneous hormones treatment (i.e., hormonal contraceptives, postmenopausal hormone therapy);
- any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Florence, Italy
- Florence, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Florence, Italy; Florence, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.