Treatment of Migraine With Introvision, a Method of Mental Self-regulation - IntroMig: Randomised Waiting-list Control Study
Phase: NA
Conditions: Migraine, Chronic Migraine
Sponsor: Ludwig-Maximilians - University of Munich

 
 
30.03.2025 
 
 
Introvision in Migraine – IntroMig 
 
NCT03507400 
 
 
 
Klinikum der Universität München 
Neurologische Klinik und Poliklinik 
Direktorin: Prof. Dr. med. Marianne Dieterich 
In Assoziation mit dem 
Institut für Klinische Neuroimmunologie und dem 
Institut für Schlaganfall- und Demenzforschung 
 
 

 
1 
Study Protocol 
 
 
1.1 
Research Project 
Introvision in Migraine - IntroMig 
Clinical Trials Number 
NCT03507400 
 
Proposers 
Dr. med. Monika Empl 
 
Neurology Consultant 
Ludwig-Maximilians University Munich 
Department of Neurology 
Hospital of the Ludwig-Maximilians-University (LMU) Munich - Großhadern 
Marchioninistraße 15 
D- 81377 Munich 
Telephone: + 49 89-4400-73906 
E-mail: monika.empl@med.uni-muenchen.de 
 
Univ.-Prof. Dr. med. Andreas Straube 
Senior Physician 
Department of Neurology 
Ludwig-Maximilians University Munich 
Hospital of the Ludwig-Maximilians-University (LMU) Munich - Großhadern 
Marchioninistraße 15 
Telephone: +48 89-4400-73901 
E-Mail: Andreas.Straube@med.uni-muenchen.de 
 
Univ.-Prof. Dr. Angelika C. Wagner 

Pedagogic Psychology 
Department of educational science 
Research Group Introvision, University of Hamburg 
Bogenallee 11 
D - 20144 Hamburg 
Telephone: +49 40-42838-7990 
E-Mail:  Angelika.Wagner@uni-hamburg.de 
 
 
Table of contents 
1. Hypothesis 
2. Study type 
3. Study design and discussion of ethic-legal issues 
4. Capability of informed consent 
5. Compensation for subjects and patients, additional costs, insurance 
6.   Data protection 
 
1. 1. 
Hypothesis 
Is Introvision, a technique to reduce stress, effective in reducing the number of headache days 
per month in patients with episodic migraine (diagnosed according to IHS 3 beta), episodic 
migraine and episodic tension type headache or chronic migraine 3 months after Introvision 
(primary  outcome measure) compared to the waiting list group. Secondary outcome measures 
are efficacy in reduction of headache intensity, acute medication, impact of headache 
(headache impact test -6; HIT-6) and patients‘ overall satisfaction with treatment. Do patients 
improve in headache self-efficacy, measured with the Headache Management Self-Efficacy 
Scale Short Form (HMSE-G-SF). 
 
2. Study type 
monozentric randomized waiting-list-control study (‚investigator-driven’). 
 
3. 3. 
Study design and discussion of ethic-legal issues 
 
 
Inclusion criteria: 

1. minimum age is 18 years  
2. episodic migraine (at least 5 headache days per month), episodic migraine and episodic 
tension type headaceh (at least 5 migrainous headache days) or chronic migraine (more 
than 15 headache days per month, out of which at least 8 migrainous headache days for 
three months), diagnosed according to IHS 3 beta.  
3. stable headache-preventative medication  
4. stable non-medication preventative measures (for instance regular sports) 
5. written informed consent  
 
Exclusion criteria: 
1. other symptomatic headaches 
2. other primary headaches (Cluster headache, trigeminal neuralgia,  
   idiopathic facial pain, new daily persistent headache)  
3. manifest severe depression (BDI-FS > 13 points) 
4. drug- or alcohol abuse 
5. non-compliance, especially missing entries in the headache diaries  
6. active psychosis 
 
For the study, the following data are collected:  
- 
last name, first name, date of birth, age, sex of the patients  
- 
number and intensity of headache days per month, documented in headache diary  
- 
number of days with acute medication against headaches 
- 
Beck-Depression-Inventory: Fast-Screen to document mood  
- 
Headache Management Self-Efficacy Scale Short Form (HMSE-G-SF) 
- 
number of KAW-exercises per week (0-1, 1-3, >3) 
- 
patients‘ global satisfaction with treatment 
- 
HIT-6 questionaire (Headache-Impact-Test) to measure impact of headaches. 
 
  
 

According to our previous experience with comparable study designs, we do not expect any 
lasting psychological stress for the subjects. There are no risks to the physical health of the 
subjects. 
No additional investigations are needed for the study.  
Due to the above-mentioned apects no serious adverse events are to be expected. In case of 
serious adverse events both the director of the clinic as well as the ethics committee will be 
informed immediately.  
 
4. 4. 
Ability to agree 
The study includes only patients who can decide on their own to participate in the study. Only 
patients with a minimum age of 18 years will be included. Patients are informed in detail in 
writing and orally about aims and procedure oft he study. The written information of the study 
as well as the form for the Declaration of consent are attached to this proposal. 
 
5. 5. 
Remuneration of subjects and patients, additional costs, insurance 
There is no remuneration for participants. Secondary costs due to additional diagnostics or a 
prolonged hospital stay are not to be expected.   
Dr. Monika Empl trains as certified instructor of Introvision, to be able to teach Introvision to 
study participants. There is no separate remuneration for the investigator, however, if a 
sponsor is found, an allowance (also for travelling expenses) is provided for the Introvision 
instructors as well as for the investigator.  An enquiry for sponsorship will be sent to the Klaus-
Grawe-Foundation, Zurich. 
An insurance contract won’t be effected, as in this research project no procedures with not 
very low risks for participants are planned. Study-related trips of the participants to the study 
are not insured. It is a therapy offer. 
 
6.   Data protection 
The data protection of the participants is given highest priority:  Only the most important 
personal data are collected (first name, last name, date of birth, age, sex). All collected data 
will be treated confidentially. They are stored or saved without a name or date of birth under a 
code number (pseudonymised). Material containing information about individual persons is 
locked and kept separate from the encoded data. Medical confidentiality and applicable data 
protection laws are respected. Data analysis is only be carried out by hospital staff, who are 
all subject to confidentiality. No individualized data will be passed on to a third party. 
Participants are informed about these procedure. The above mentioned points are explained 
in the patient information and in particular in the declaration of consent for data protection. 
 

 
 
 
Dr. med. Monika Empl 
 
 
 
 
Neurology Consultant 
 
 
 
 
Prof. Dr. med. Andreas Straube 
 
 
 
 
Senior Physician of the Department of Neurology  
 
 
  
 
 
 
Prof. Dr. Angelika C. Wagner 
Pedagogic psychology, Department of educational science 
Research Group Introvision, University of Hamburg