We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH).
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Therapeutic effect of the ATI neurostimulator in patients with refractory CH
headache
Secondary outcome
-Quality of life
-reduction in medication
-cost-effectiveness analysis
Background summary
The pain and autonomic symptoms of cluster headache (CH) result from activation
of the trigeminal
parasympathetic reflex, mediated through the sphenopalatine ganglion (SPG).
Study objective
We investigated the safety and efficacy of on-demand SPG stimulation for
chronic CH (CCH).
Study design
A, multiple CH attack study of an implantable on-demand SPG neurostimulator was
conducted in
patients suffering from refractory CCH. The design is cross-over, each patient
was randomly treated with full or placebo
stimulation. Pain relief at 15 minutes following SPG stimulation and device- or
procedure-related serious adverse
events (SAEs) were evaluated
Intervention
Implantation of the ATI neurostimulator in the sphenopalatine ganglion
Study burden and risks
On-demand SPG stimulation using the ATI Neurostimulation System is an effective
novel therapy for CCH
sufferers, with dual beneficial effects, acute pain relief and observed attack
prevention, and has an acceptable safety
profile compared to similar surgical procedures (reference Schoenen et al)
Boelelaan 1089A
Amsterdam 1081HV
NL
Boelelaan 1089A
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
-18-65 years old.
-classified with chronic cluster headache ICHD-3 criteria 3.1.2
-reported headache frequentie of 10 weekly
-Patient reported dissatisfaction with current headache treatments.
-Patient was able to distinguish cluster headaches from other headaches.
-knowledge dutch language
Exclusion criteria
-Patient had a change in type or dosage of preventive headache medications within one month of enrollment.
-Women of childbearing age who were pregnant, nursing, or not using contraception.
-Patient had undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned implant site within the last four months.
-Patient had been treated with radiation to the facial region within the last six months.
-Patient had been diagnosed with any major infectious processes including osteomyelitis or primary or secondary malignancies of the face that were active or required treatment in the past six months.
Patient had another significant pain problem that might confound the study assessments in the opinion of the investigator.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50300.029.14 |
| OMON | NL-OMON21021 |