Intervention
Conditions
Keywords
migraine headache, episodic
Brief summary
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
Detailed description
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).
Interventions
DEVICEactive neuromodulation for episodic migraine headache
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
DEVICEplacebo neuromodulation for episodic migraine headache
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Sponsors
Scion NeuroStim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with episodic migraine at least 6 months before study * at least 3 consecutive months of stable migraine headaches before study * at least 4-14 headache days per month, of which 4-14 may be migraines * must not have failed on more than 2 classes of migraine preventatives
Exclusion criteria
* previous use of the experimental device * pregnant * using more than 1 concurrent migraine preventive * history of cardiovascular disease * work night shifts * diagnosed with vestibular migraine * menstrual migraines exclusively * diagnosed with post-traumatic migraine * have a history of unstable mood or anxiety disorder * use a hearing aid * have a cochlear implant * have chronic tinnitus * have temporomandibular joint disease * diagnosed with traumatic brain injury * diagnosed with neurological disease other than headaches * diagnosed vestibular and/or balance dysfunction * history of abusing alcohol or other drugs * are experiencing medication overuse headaches * have had eye surgery in the previous 3 months * have had ear surgery in the previous 6 months * have active ear infections or a perforated tympanic membrane * have participated in another clinical trial in the last 30 days * are currently participating in another clinical trial * using Botulinum toxin-based treatments for migraines or cosmetic reasons * taking anti-emetics more than 2 times per week (consistently)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine Headache Days (MHD) | 1 month of baseline recordation followed by 84 days of device use | comparison of MHD recorded in baseline month versus 3rd month of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Usage | 1 month of baseline recordation followed by 84 days of device use | reduction in acute, prescribed medications in month 3 of treatment versus baseline month |
| Change in Headache Pain | 1 month of baseline recordation followed by 84 days of device use | reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month |
| Change in Quality of Life | 1 month of baseline recordation followed by 84 days of device use | comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3 |
| Change in Depression | 1 month of baseline recordation followed by 84 days of device use | comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3 |
| Normalized Reduction in Migraine Headache Days | 1 month of baseline recordation followed by 84 days of device use | comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo |
| Change in Sleep Quality | 1 month of baseline recordation followed by 84 days of device use | comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3 |
| Additional Treatment Time | 1 month of baseline recordation followed by 168 days of device use | comparison of MHD recorded in baseline month versus 6th month of treatment |
| Sustained Reduction in Migraine Headache Days | 1 month of baseline recordation followed by 252 days of device use | comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9 |
| Change in Anxiety | 1 month of baseline recordation followed by 84 days of device use | comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3 |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BID Placebo Participants self-administered twice-daily inactive/sham treatments for 12 weeks followed by twice-daily active treatments for 12 weeks followed by a post-treatment observation period lasting 12 months. | 14 |
| BID Active Participants self-administered twice-daily treatments for 12 weeks followed by twice-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months. | 15 |
| QD Active Participants self-administered once-daily treatments for 12 weeks followed by once-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months. | 16 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Post-treatment Observation Period | Study Termination | 3 | 6 | 5 |
| Treatment Period 1 | Adverse Event | 1 | 0 | 2 |
| Treatment Period 1 | Withdrawal by Subject | 0 | 4 | 0 |
| Treatment Period 2 | Lost to Follow-up | 0 | 0 | 1 |
| Treatment Period 2 | Study Termination | 6 | 3 | 3 |
Baseline characteristics
| Characteristic | BID Placebo | BID Active | QD Active | Total |
|---|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12.2 | 43.9 years STANDARD_DEVIATION 11.3 | 43.5 years STANDARD_DEVIATION 10.8 | 43.87 years STANDARD_DEVIATION 11.28 |
| Monthly migraine days | 7.9 days STANDARD_DEVIATION 1.7 | 7.7 days STANDARD_DEVIATION 1.9 | 7.5 days STANDARD_DEVIATION 2.4 | 7.8 days STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 14 Participants | 37 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 4 / 14 | 7 / 15 | 4 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 | 0 / 16 |
Outcome results
Primary
Change in Migraine Headache Days (MHD)
comparison of MHD recorded in baseline month versus 3rd month of treatment
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Additional Treatment Time
comparison of MHD recorded in baseline month versus 6th month of treatment
Time frame: 1 month of baseline recordation followed by 168 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Anxiety
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Depression
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Headache Pain
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Medication Usage
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Quality of Life
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Change in Sleep Quality
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Normalized Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Time frame: 1 month of baseline recordation followed by 84 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
Secondary
Sustained Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
Time frame: 1 month of baseline recordation followed by 252 days of device use
Population: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.