SPG Neurostimulation in Cluster Patients
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|ClinicalTrials.gov Identifier: NCT02510729|
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Cluster Headache||Device: Neurostimulation Device: Sham stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: SPG neurostimulation
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Placebo Comparator: Sham Stimulation
Sham stimulation with amplitude=0
Device: Sham stimulation
- Incidence of cluster-like attacks and cephalic autonomic symptoms [ Time Frame: 0-60 min ]Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.
- Mechanical detection and pain thresholds [ Time Frame: 0-60 min ]Difference in mechanical detection and pain thresholds in the face between LF and sham stimulation measured by pin-prick and von Frey hairs.
- Plasma concentrations of PACAP38 and VIP [ Time Frame: 0-60 min ]Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
- Cardiac autonomic regulation (HRV) [ Time Frame: 0-60 min ]Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
- Mean arterial blood pressure and heart rate [ Time Frame: 0-60 min ]Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
- Headache intensity [ Time Frame: 0-60 min ]Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510729
|Danish Headache Center|
|Copenhagen, Glostrup, Denmark, 2600|
|Principal Investigator:||Messoud Ashina, Prof.||Danish Headache Center|