- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999060
Trigeminal Brainstem Mapping
Brainstem Mapping of Nociceptive Trigeminal Input
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hamburg, Germany, 20246
- UKE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Electric Stimulation
|
Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
through study completion, an average of 9 months
|
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) |
through study completion, an average of 9 months
|
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) |
through study completion, an average of 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Statistical Parametric Map calculated from the fMRI data in the cerebellum
Time Frame: through study completion, an average of 9 months
|
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
|
through study completion, an average of 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Arne May, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TrigeminalBrainstemMapping
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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