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

Brief Summary:
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.

Condition or disease Intervention/treatment Phase
Chronic Cluster Headache Device: Neurostimulation Device: Sham stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: SPG neurostimulation
Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz
Device: Neurostimulation
Placebo Comparator: Sham Stimulation
Sham stimulation with amplitude=0
Device: Sham stimulation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Plasma concentrations of PACAP38 and VIP [ Time Frame: 0-60 min ]
    Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.

  3. 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.

  4. 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.

  5. Headache intensity [ Time Frame: 0-60 min ]
    Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic cluster patients

Exclusion Criteria:

-


Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Danish Headache Center
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Layout table for investigator information
Principal Investigator: Messoud Ashina, Prof. Danish Headache Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Song Guo, MD, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02510729    
Other Study ID Numbers: H-15005609
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases