Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study

NCT04299958 | Completed

• 1 other identifier: PI 20-1638
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Observational analytic study with prospective cohort design that aim to describe the presence of typical features of migraine in a cohort of nummular headache patients. The aim of the study is to analyze family history, epidemiology, clinical description, presence of prodromes, postdromes and response to treatment.

Conditions

Nummular Headache; Migraine; Headache Disorders, Primary

Keywords

Nummular headache

Outcome Measures

Primary Outcomes (9)

• Family history of migraine

  To assess family history of migraine headache in nummular patients. We will build family tree up to 3 generations and we will ask patients to complete it by questioning their relatives.

  Through study completion, an average of 1 month

• Epidemiological pattern

  To determine age of onset, age when they were diagnosed, temporal pattern and frequency of headache.

  Through study completion, an average of 1 month

• Clinical phenotype

  To assess the clinical characteristics of nummular headache, analyzing the presence of typical features of migraine. Patients will complete a prospective headache diary for 15 days.

  Through study completion, an average of 1 month

• Presence of associated symptoms

  To assess the presence of symptoms such as nausea, vomiting, dizziness during the headache episodes.

  Through study completion, an average of 1 month

• Presence of prodromes

  To assess the presence of typical migraine prodromes before the headache episodes.

  Through study completion, an average of 1 month

• Presence of postdromes

  To assess the presence of typical migraine postdromes after the headache episode.

  Through study completion, an average of 1 month

• Presence of sensory disturbances

  To evaluate the presence of sensory changes such as hypoesthesia, hyperalgesia or allodinia upon examination.

  Through study completion, an average of 1 month

• Response to acute treatment

  To describe response to prior acute medications.

  Through study completion, an average of 1 month

• Response to prophylactic treatment

  To assess response to prior prophylactic treatments.

  Through study completion, an average of 1 month

Interventions

Patient diary OTHER

In the first visit they will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.

Eligibility Criteria

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

Study Population

Patients with definite diagnosis of nummular headache that visit the headache outpatient clinic of Valladolid University Hospital.

You may qualify if:

• Diagnosis of Nummular Headache (NH) according to the International Classification of Headache Disorders, 3rd version (ICHD-3).
• More than 3 months of NH evolution.
• No better accounted for by another ICHD-3 diagnosis.
• Older than 18 years.
• Capable of prospectively register headache characteristics in a diary.
• Ability to provide informed consent form.

You may not qualify if:

• Other primary or secondary headache, except for infrequent tension-type headache or medication overuse headache.
• Major psychiatric disorders.
• Alcoholism or drug use.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario Valladolid

Valladolid, 47003, Spain

Location

Related Publications (5)

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.

  PMID: 12058099 BACKGROUND

• Trigo J, Garcia-Azorin D, Martinez Pias E, Sierra A, Chavarria A, Guerrero AL. Clinical characteristics of nummular headache and differentiation between spontaneous and posttraumatic variant: an observational study. J Headache Pain. 2019 Apr 8;20(1):34. doi: 10.1186/s10194-019-0981-4.

  PMID: 30961529 BACKGROUND

• Garcia-Azorin D, Trigo-Lopez J, Sierra A, Blanco-Garcia L, Martinez-Pias E, Martinez B, Talavera B, Guerrero AL. Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study. Cephalalgia. 2019 Dec;39(14):1818-1826. doi: 10.1177/0333102419863023. Epub 2019 Jul 4.

  PMID: 31272194 BACKGROUND

• Cuadrado ML, Lopez-Ruiz P, Guerrero AL. Nummular headache: an update and future prospects. Expert Rev Neurother. 2018 Jan;18(1):9-19. doi: 10.1080/14737175.2018.1401925. Epub 2017 Nov 9.

  PMID: 29103335 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: April 1, 2020
• Primary Completion: March 25, 2023
• Study Completion: April 25, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (1)