Migraine
Conditions
Keywords
Headache, Migraine, Refractory, Chronic, Pain
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.
Interventions
DEVICEPrecision
Implantable Neurostimulator
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be diagnosed with multiple migraines per month of moderate to severe intensity; * Be refractory to medication; * Be an appropriate candidate for the surgical procedures required fo this study; * Be willing and able to comply with all study related procedures; * Be capable of reading and understanding patient information materials and giving written informed consent.
Exclusion criteria
* Have onset of headache after age 50; * Are current substance abusers (including alcohol and illicit drugs); * Have a significant psychiatric disorder; * Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant); * Have had nerve stimulation for pain relief. * Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; * Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect. * Have a condition currently requiring or likely to require the use of MRI or diathermy; * Have an active implantable device; * Are pregnant or lactating or planning to become pregnant in the next 14 months; * Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Hours of Headache | 12 weeks |
| Number of Days With 4 or More Hours of Headache | 12 Weeks |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Stimulation (Treatment Group) Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study. | 5 |
| Sham Stimulation (Control Group) Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on. | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Research Site Staff Relocation | 5 | 3 |
Baseline characteristics
| Characteristic | Active Stimulation (Treatment Group) | Sham Stimulation (Control Group) | Total |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 15.5 | 55.6 years STANDARD_DEVIATION 5.5 | 50.7 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United Kingdom | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 5 | 3 / 4 |
| serious Total, serious adverse events | 4 / 5 | 2 / 4 |
Outcome results
Primary
Number of Days With 4 or More Hours of Headache
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Stimulation (Treatment Group) | Number of Days With 4 or More Hours of Headache | NA Days |
| Sham Stimulation (Control Group) | Number of Days With 4 or More Hours of Headache | NA Days |
Primary
Number of Hours of Headache
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Stimulation (Treatment Group) | Number of Hours of Headache | NA Hours |
| Sham Stimulation (Control Group) | Number of Hours of Headache | NA Hours |