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

Application form for non-AMG/non-MPG studies 
(in addition, a separate study protocol must be submitted) 
(See also "explanations of the application for non-AMG/non-MPG studies) 
1 
Applicant: Name, Address, Tel./Fax-No.: 
 
 
Dr. med. Monika Empl 
Neurology Consultant 
Department of Neurology 
Department of Neurology 
Ludwig-Maximilians University Munich 
University Hospital Munich-Großhadern 
Marchioninistraße 15 
D- 81377 Munich  
Tel.: +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 
University Hospital Munich-Großhadern 
Marchioninistraße 15 
D- 81377 Munich 
Telephone: +49 89-4400-73900 
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 
 
2 
Title of the research project: 
Introvision in migraines and headaches-
IntroMig 
 
3 
Training data and research experience:  
See enclosed application, page 2f 
4 
Monocentric or multicenter study:  
 
In multicenter studies:   
 
Head of the clinical trial of other test 
centres, central evaluation point 
Votes of other ECs  
 
 
 
Monocentric study 
             
multicenter study                   O 
 
 
- n.a. - 
 

 
2 
5 
Declaration that the principles of the 
Helsinki Declaration are taken into 
account in their current version.  
 
 
 
I/we declare that the principles of the 
Helsinki Declaration are taken into 
account in the current version 
 
 
Munich, 22.10.2015 
 
 
(Dr. med. Monika Empl, 
  On behalf of all applicants) 
 
6 
Study-related burdens:    
 
a) Radiation exposure 
 
If yes: 
 
 
 
 
 
 
b) Diagnostic investigations 
 
 
 
c) Blood/Tissue Collection 
 
 
 
Yes 
О 
No  
 
 
I/we declare that prior to the study the 
approval of the BFS is obtained. 
 
 
Yes 
О 
No  
 
 
 
Yes 
О 
No  
 
 
7 
Wissenschaftliche Angaben zum 
Forschungsvorhaben: 
 
See enclosed application, page 3ff 
7.1  Study Objective 
 
See enclosed application, page 5f 
 
 
 
 
 
 
7.2   Study Design 
 
 
With control group       
Yes 
                       
No  
О            
 
With healthy volunteers 
Yes 
О 
No  
 
 
 
7.3  Case number estimation and evaluation 
concept     
 
Yes 
    
Mrs. Dr. Hoster, Institute for Biometry 
and Epidemiology (IBE), LMU 
See enclosed application, page 7f 
 
                    

 
3 
 
No  
О      Please explain 
      
 
7.4 Statistical advice by 
 
 
Mrs Dr. Hoster, IBE, LMU Munich 
7.5  Study duration  
Expected Start Date: 01.12.2015 
 
Expected End: 31.12.2016 
8 
Discussion of ethical-legal issues 
See enclosed application, page 8 
 
8.1. 
Discussion of the disadvantages, risks, 
burdens and potential benefits of the 
study 
 
8.2. 
Inclusion of persons not able to consent 
 
 
If provided: 
Provided                                  О 
Not provided                             
 
Indication of reasons 
 
8.3. 
Research on minors 
 
 
If provided: 
 
Provided                                  О 
Not provided                             
 
Indication of reasons 
 
9 
Data protection 
 
 
 
If pseudonymised use 
 
Irreversible anonymised use of 
samples/data (without reference to 
persons)                                     О             
 
pseudonymised use of  
samples/ persons)                                   
Encryption) 
                         
Information on how the encryption code 
is formed, who has access to the 
encryption code, reasons for decryption 
and how long the data/samples be kept 
 
See enclosed application, page 8f 
 
10 Insurance:  
Declaration that an insurance policy is / 
was completed                         О               
 
Why insurance is  
not necessary                                          
 
See enclosed application, page 9 
 
 
A road insurance has been completed       

 
4 
Yes 
О 
No  
 
 
11 Financing: 
A) Financing of the research project  
B) rewarding doctors/patients/volunteers 
 
See enclosed application, page 9 
 
12 Expenditure compensation for the EC:  
 
 
The costs of expenditure compensation 
are taken over                                         
 
Application for reduction of expenditure 
compensation  (explanation to attach)       
 
 
Billing address (if different from the 
address of the applicant):  
  
 
 
 
Date, Signature 
 
 
22.10.2015