Complaints & course of headache in the context of Chiari malformation type 1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025285

Enrollment

150

Registered

2021-05-06

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q07.0

Interventions

Group 1: Patients with Chiari malformation type 1 We would like to reach the patient on one examination day by telephone or in person in the course of the anyway scheduled follow-up appointment to as

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Patients with Arnold-Chiari malformation type 1. - Age = 18 Subproject with OCT examination Inclusion criteria: - Patients with consistent cough headache according to ICDH-3 attributed to Arnold-Chiari malformation type I (ICHD-3). - Age ¬= 18

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Other secondary headaches - Space-occupying diseases of the brain (subural hematomas, neoplasms) - Age < 18 - Tonsillar descent on cranial MRI < 5 mm. - Lack of written informed consent or lack of capacity to give consent. Subproject with OCT examination Exclusion criteria: - Other secondary headaches - Age < 18 - Ocular diseases (especially glaucoma, age-related macular degeneration) - Lack of written consent or lack of ability to give consent

Design outcomes

Primary

Measure	Time frame
Descriptive analysis of the frequencies, intensity, and type of headaches	—

Secondary

Measure	Time frame
Elicitation of prognostic (e.g., sociocultural, psychosocial, clinical, anatomical, imaging, surgical) factors that influence the headache course. The purpose of this study is to investigate the effect of this operation on the complaints, answering the following questions: 1. detailed semiological description (according to ICHD-3 criteria) of the headache symptoms as well as concomitant symptoms in the context of the diagnosis. 2. does surgical therapy lead to a change in headache frequency/type/intensity? 3. does surgical treatment result in a change in other symptoms (other than headache)? 4. is there any postoperative change in existing imaging findings such as depth of cerebellar depression, length/diameter of cavity formation (so-called syrinx)? 5. are there anatomical or clinical peculiarities between patients with or without headache? 6. subproject: In a subpopulation with persisting cough headache in Arnold-Chiari-1 malformation, is there a pathological finding of the ocular fundus in optical coherence tomography? Therefore, in summary, the following target variables can be defined: Primary: analysis of the number of intensity & headache days per month. Secondary: Semiology of headache, anatomical differences, course of headache regarding conservative and surgical therapy modalities as well as socio-cultural, psycho-social, clinical, anatomical, imaging factors influencing the course. Furthermore (subproject) Objective changes in OCT especially of the peripapillary retinal nerve fiber layer (pRNFL) and with regard to macular changes.	—

Measure

Time frame

Elicitation of prognostic (e.g., sociocultural, psychosocial, clinical, anatomical, imaging, surgical) factors that influence the headache course. The purpose of this study is to investigate the effect of this operation on the complaints, answering the following questions: 1. detailed semiological description (according to ICHD-3 criteria) of the headache symptoms as well as concomitant symptoms in the context of the diagnosis. 2. does surgical therapy lead to a change in headache frequency/type/intensity? 3. does surgical treatment result in a change in other symptoms (other than headache)? 4. is there any postoperative change in existing imaging findings such as depth of cerebellar depression, length/diameter of cavity formation (so-called syrinx)? 5. are there anatomical or clinical peculiarities between patients with or without headache? 6. subproject: In a subpopulation with persisting cough headache in Arnold-Chiari-1 malformation, is there a pathological finding of the ocular fundus in optical coherence tomography? Therefore, in summary, the following target variables can be defined: Primary: analysis of the number of intensity & headache days per month. Secondary: Semiology of headache, anatomical differences, course of headache regarding conservative and surgical therapy modalities as well as socio-cultural, psycho-social, clinical, anatomical, imaging factors influencing the course. Furthermore (subproject) Objective changes in OCT especially of the peripapillary retinal nerve fiber layer (pRNFL) and with regard to macular changes.

—

Countries

Germany

Contacts

Public ContactCem Thunstedt

Universitätklinikum München Neurologie

cemthunstedt@gmail.com01715276528

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026