Clinical Research Directory

Mind Body Balance for Pediatric Migraine

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Responding With Evidence and Access for Childhood Headaches

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

Treatment Response to GON Pulsed Radiofrequency in Elderly Patients With Chronic Migraine

Headache disorders are highly prevalent in older adults, yet their management remains challenging due to comorbidities, polypharmacy, and the paucity of evidence derived from geriatric populations. Most randomized clinical trials exclude elderly patients, underscoring the need for effective and safe non-pharmacological treatment strategies for headache in this age group. Greater occipital nerve blocks are commonly used in the treatment of migraine and other headache disorders; however, their clinical benefit is often transient. Pulsed radiofrequency (PRF) has been introduced as a minimally invasive technique aimed at prolonging therapeutic effects through neuromodulation without causing structural neural damage. Although greater occipital nerve pulsed radiofrequency (GON-PRF) has demonstrated efficacy in various headache disorders, its effectiveness in patients aged 65 years and older has not been adequately investigated. The primary aim of this study is to evaluate the effectiveness of GON-PRF in patients aged ≥65 years with chronic migraine by assessing changes in pain intensity, monthly headache days, and monthly severe headache days. The secondary aim is to identify geriatric predictors of treatment response, including frailty status and the Geriatric Nutritional Risk Index (GNRI), in order to support individualized treatment strategies for older adults.

Adolescent Lifestyle Medicine Headache Study

The goal of this pilot clinical trial is to assess the implementation of a 7-week Lifestyle Medicine intervention for adolescents with headache. The main question it aims to answer is: Is it feasible to implement a Lifestyle Medicine curriculum for adolescents with headache and secondarily, does this intervention show any signal for improving headache symptoms? Participants will be divided into two groups based on the order of their enrollment. After consent, they will be asked to complete 3 symptom surveys: PedMIDAS-6w, PHQ-A and GAD-7, in addition to a Lifestyle Survey. They will attend group medicine visits virtually, facilitated by the study team. Each week will address a different tenant of Lifestyle Medicine (such as eating or sleep) and participants will create a SMART goal to work on for the week. At the end of the seven weeks, they will repeat these symptom and lifestyle surveys. During the seven weeks, they will also keep a daily symptom diary, which will be texted to their phones through a HIPPA-compliant RedCAP database.

Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP

Aims: To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination. Methods: In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep. In addition, patients' characteristics will be investigated as follows: 1. Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure) 2. Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle) 3. Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS) 4. Depression, evaluate by Beck's Depression Inventory 5. Quality of life, evaluate by 36-Item Short Form Survey (SF-36) 6. Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI) 7. Aura of headache 8. Episodic or chronic headache (If patient diagnosed as migraine.) 9. Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin. Importance: In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.

Trial Designs for Evaluating Migraine Treatment

The study aims to estimate treatment effects in randomized controlled trials (RCT) and a balanced placebo design (BPD) to specify how contextual and psychological factors interact in acute migraine treatment and influence adverse event occurrence. Using a clinical within-subjects design, patients with episodic migraine will receive six treatment conditions in a randomized order.

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption

Observational analytic study with a prospective cohort design. Patients with episodic and chronic migraine that have responded to monoclonal antibodies (mAbs) versus calcitonin gene-related peptide (CGRP) or its receptor with positive response will be included. A headache diary will be completed in a daily basis. The primary outcome will be the time elapsed between the discontinuation of the monoclonal antibody and the return to the clinical situation at the moment of the mAbs onset. The potential variables that may be associated with a more sustained benefit will be explored.