Comparison of Amitriptyline to Lifestyle Modification as Intervention for Vestibular Migraine
Withdrawn before enrolling · Early Phase 1
Conditions studied: Vestibular Migraine
In brief
Vestibular migraine (VM) is one of the most common causes of vertigo attacks, affecting 1 - 5% of people. People with vestibular migraine have lower quality of life compared to others and some may experience completely debilitating symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. There is evidence the medication amitriptyline in isolation and also our lifestyle modification intervention in isolation can each help reduce symptoms of dizziness and headache in patients with VM. However, these data are observational and subject to various types of bias. The purpose of the current investigation is to determine outcomes from each intervention using randomized allocation of participants diagnosed with VM into either the amitriptyline arm or the lifestyle modification arm. The investigators will measure for change in dizziness using the Dizziness Handicap Inventory (DHI) and for change in headache using the Headache Disability Inventory (HDI). For participants in the lifestyle modification arm, the investigators will also measure for change in lifestyle factor to determine improvement on those intervention factors. Measures will be obtained pre-intervention to establish baseline, at 30 days, 60 days, and 90 days. the investigators will also re-survey participants one year after initiation of intervention to determine adherence and status.
Key facts
- Study ID
- NCT06417684
- Run by
- Vanderbilt University Medical Center
- People needed
- 0
- Starts
- 2024-06-19
- Expected to finish
- 2026-03-11
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English-speaking adults
- Diagnosed with Definite Vestibular Migraine
- Currently prescribed rescue medication for migraine is acceptable
You may not qualify if…
- Non-English speaking
- Diagnosed and undergoing treatment for active Definite Meniere's disease
- Already using amitriptyline
- Contraindicated for intervention with amitriptyline including:
- Patients with Hepatic Impairment
- Patients with Renal Impairment
- Pregnancy
- Breastfeeding
- Elderly Patients
- Allergy to amitriptyline
- Heart attack
- Used an MAO inhibitor in the past 14 days
- Used an "SSRI" antidepressant in the past 5 weeks
- Bipolar disorder (manic-depression) or schizophrenia
- Mental illness or psychosis
- Stroke
- Seizures
- Diabetes
- Glaucoma
- Problems with urination
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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