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Trigeminal Brainstem Mapping

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ClinicalTrials.gov Identifier: NCT03999060
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE June 28, 2019
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Statistical Parametric Map calculated from the fMRI data on brainstem level [ Time Frame: through study completion, an average of 9 months ]
    At a statistical threshold of T-value 3 we will observe a somatotopical arrangement in the brainstem below the pons: Expected location for V1: within radius of 10 mm around the MNI coordinates (-1,-48,-75); Expected location for V2: within radius of 10 mm around the MNI coordinates (-4,-47,-69) Expected location for V3: within radius of 10 mm around the MNI coordinates (-1,-46,-66) Expected location for GON: within radius of 10 mm around the MNI coordinates (-1,-45,-64)
  • Statistical Parametric Map calculated from the fMRI data in the thalamus [ Time Frame: through study completion, an average of 9 months ]
    At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the thalamus: Expected location for V1: within radius of 10 mm around the MNI coordinates (11,-5,6); Expected location for V2: within radius of 10 mm around the MNI coordinates (13,-11,5) Expected location for V3: within radius of 10 mm around the MNI coordinates (12,-10,5) Expected location for GON: within radius of 10 mm around the MNI coordinates (15,-12,-7)
  • Statistical Parametric Map calculated from the fMRI data in the insula [ Time Frame: through study completion, an average of 9 months ]
    At a statistical threshold of T-value 4 we will observe a somatotopical arrangement in the insula: Expected location for V1: within radius of 10 mm around the MNI coordinates (38,-15,8); Expected location for V2: within radius of 10 mm around the MNI coordinates (37,-8,-5) Expected location for V3: within radius of 10 mm around the MNI coordinates (39,2,-11) Expected location for GON: within radius of 10 mm around the MNI coordinates (38,-12,-3)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03999060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Statistical Parametric Map calculated from the fMRI data in the cerebellum [ Time Frame: through study completion, an average of 9 months ]
  • Statistical Parametric Map calculated from the fMRI data in the periaqueductal gray (PAG) [ Time Frame: through study completion, an average of 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trigeminal Brainstem Mapping
Official Title  ICMJE Brainstem Mapping of Nociceptive Trigeminal Input
Brief Summary To what extent the somatotopy of the 3 branches of the trigeminal nerve (V1,V2,V3) as well as the greater occipital nerve (GON) in the brainstem but also in the thalamus and the insula can be mapped using functional imaging and BOLD in humans is not known but might play an important role in imaging headache diseases. The aim is to map their somatotopy by random stimulation of V1, V2, V3 and the GON with painful electrical input during acquisition of BOLD-fMRI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Headache Disorders, Primary
  • Migraine
Intervention  ICMJE Device: Electric Current Stimulation
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
Study Arms  ICMJE Experimental: Electric Stimulation
Intervention: Device: Electric Current Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
32
Actual Study Completion Date  ICMJE September 27, 2019
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy
  • suitable fo MRI

Exclusion Criteria:

  • headache disease
  • psychological disorder
  • pregnancy
  • all exclusion criteria necessary for imaging in a 3 T MRI scanner
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999060
Other Study ID Numbers  ICMJE TrigeminalBrainstemMapping
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Group results will be presented at international conferences as well as published in international peer-reviewed journals
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arne May, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP