Chronic Cluster HeadacheNCT02510729
SPG Neurostimulation in Cluster Patients
A study testing Neurostimulation in people with Chronic Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic cluster patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
We hypothesized that LF stimulation of the SPG would increase parasympathetic outflow, activate sensory afferents and provoke a cluster-like attack.
Read the 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.
- Conditions
- Chronic Cluster Headache
- Being tested
- Neurostimulation, Sham stimulation
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationDevice
Sham stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| SPG neurostimulation | Active comparator | Sphenopalatine ganglion (SPG) neurostimulation of 20 Hz Receives: Device: Neurostimulation |
| Sham Stimulation | Placebo comparator | Sham stimulation with amplitude=0 Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cluster-like attacks and cephalic autonomic symptoms
Difference in incidence of cluster-like attacks and cephalic autonomic symptoms between LF and sham stimulation.
Measured: 0-60 min
Secondary outcomes (5)
Mechanical detection and pain thresholds
Difference in mechanical detection and pain thresholds in the face between LF and sham stimulation measured by pin-prick and von Frey hairs.
Measured: 0-60 min
Plasma concentrations of PACAP38 and VIP
Difference in plasma concentrations of PACAP38 and VIP between LF and sham stimulation.
Measured: 0-60 min
Cardiac autonomic regulation (HRV)
Changes in cardiac autonomic regulation (HRV) between LF and sham stimulation and during cluster attacks measured by continious ECG.
Measured: 0-60 min
Mean arterial blood pressure and heart rate
Difference in mean arterial blood pressure and heart rate between LF and sham stimulation.
Measured: 0-60 min
Headache intensity
Difference in headache intensity measured by numerical rating scale (NRS 0-10) between LF and sham stimulation.
Measured: 0-60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Guo, Danish Headache Center
- Investigators
- Messoud Ashina, Prof., Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510729
- Sponsor's protocol ID
- H-15005609
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2015
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo S, Petersen AS, Schytz HW, Barlose 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.
PubMed 29082824
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalataine Ganglion (SPG) Stimulation in Cluster Headache Patients
- ClinicalTrials.gov ID
- NCT02510729
- Acronym / sponsor ID
- H-15005609
- Conditions
- Chronic Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPG neurostimulation | Active comparator | Device: NeurostimulationSphenopalatine ganglion (SPG) neurostimulation of 20 Hz |
| Sham Stimulation | Placebo comparator | Device: Sham stimulationSham stimulation with amplitude=0 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic cluster patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostimulation | Device | SPG neurostimulation |
| Sham stimulation | Device | Sham Stimulation |
Primary outcome
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.
5 secondary outcomes
Mechanical detection and pain thresholds
Time frame: 0-60 min
Plasma concentrations of PACAP38 and VIP
Time frame: 0-60 min
Cardiac autonomic regulation (HRV)
Time frame: 0-60 min
Mean arterial blood pressure and heart rate
Time frame: 0-60 min
Headache intensity
Time frame: 0-60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Derived from this study: PubMed 29082824Guo S, Petersen AS, Schytz HW, Barlose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, Prof. principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation in people with Chronic Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cluster-like attacks and cephalic autonomic symptoms (time frame: 0-60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.