Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SPG Neurostimulation in Cluster Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02510729
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE July 29, 2015
Last Update Posted Date August 16, 2017
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2015)
Changes in mean blood velocity in middle cerebral artery (VMCA) [ Time Frame: 0-60 min ]
Changes in mean VMCA (cm/sek) is measured by transcranial Doppler.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2015)
Changes in diameter of superficial temporal artery STA [ Time Frame: 0-60 min ]
Changes in diameter of STA (mm) is measured by ultra sound DermaScan.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPG Neurostimulation in Cluster Patients
Official Title  ICMJE Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
Brief Summary We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
Detailed Description We conducted a double-blind, randomized, sham-controlled, crossover study to investigate cluster attack induction following LF (20 Hz and 0.2-2.1 amplitude) and sham (amplitude = 0) stimulation in 20 CH patients with implanted SPG neurostimulator. In addition, we measured plasma concentrations of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal peptide (VIP), as markers for parasympathetic activation before, during and after SPG stimulation. We also investigated if LF SPG stimulation induces changes in cardiac autonomic regulation and whether any attacks induced by SPG stimulation are associated with such changes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Chronic Cluster Headache
Intervention  ICMJE
  • Device: Neurostimulation
  • Device: Sham stimulation
Study Arms  ICMJE
  • Active Comparator: SPG neurostimulation
    Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
    Intervention: Device: Neurostimulation
  • Placebo Comparator: Sham Stimulation
    Sham stimulation with amplitude=0
    Intervention: Device: Sham stimulation
Publications * Guo S, Petersen AS, Schytz HW, Barløse M, Caparso A, Fahrenkrug J, Jensen RH, Ashina M. Cranial parasympathetic activation induces autonomic symptoms but no cluster headache attacks. Cephalalgia. 2018 Jul;38(8):1418-1428. doi: 10.1177/0333102417738250. Epub 2017 Oct 30.

*   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: August 14, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2015)
30
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic cluster patients

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02510729
Other Study ID Numbers  ICMJE H-15005609
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Song Guo, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Messoud Ashina, Prof. Danish Headache Center
PRS Account Danish Headache Center
Verification Date August 2017

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