Migraine
Conditions
Keywords
REN, Nerivio, Children
Brief summary
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.
Detailed description
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust. The REN device is operated by a designated smartphone application that is downloaded to the user's phone prior first use of the Nerivio device. As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specify that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraines attacks and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), and an indication of which medications, if any, were taken within that 2-hour time window. Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice. This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in pre-adolescence migraine patients who used the Nerivio device. The following outcomes will be assessed: 1. \- Safety - Adverse events that were reported during the study's period 2. \- Efficacy - Pain relief, freedom from pain, improvement in functional disability, and improvement in migraine-associated symptoms following the treatment Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target population.
Interventions
DEVICENerivio
Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
Sponsors
Theranica
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Inclusion criteria
* Subject age is between 6 to 12 at the date of the REN treatment * Subject used the Nerivio device at least once
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device Related Adverse Events | Up to 6 months | Incidence of device-related adverse events reported by subjects throughout the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consistent Headache Relief at 2 Hours Post-treatment | up to 6 months | The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain. |
| Consistent Freedom From Headache at 2 Hours Post-treatment | up to 6 months | The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later |
| Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment | up to 6 months | The proportion of subjects reporting the presence of each of the migraine-associated symptoms (nausea/vomiting, photophobia, phonophobia) at the beginning of treatment and reported their absence 2 hours following the treatment in at least 50% of their attacks. |
| Consistent Functional Disability Relief at 2 Hours Post-treatment | up to 6 months | The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments. |
| Consistent Functional Disability Disappearance at 2 Hours Post-treatment | up to 6 months | The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-adolescents With Migraine Patients at the age of 6-11 (included) with migraines who used the Nerivio device at least once
Nerivio: Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine | 293 |
| Total | 293 |
Baseline characteristics
| Characteristic | Pre-adolescents With Migraine | — |
|---|---|---|
| Age, Customized 10<= and <11 years | 68 Participants | — |
| Age, Customized 11<= and <12 years | 151 Participants | — |
| Age, Customized 6<= and <7 years | 3 Participants | — |
| Age, Customized 7<= and <8 years | 11 Participants | — |
| Age, Customized 8<= and <9 years | 26 Participants | — |
| Age, Customized 9<= and <10 years | 34 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female (<=10 Age <11 years) | 52 Participants | — |
| Sex/Gender, Customized Female (<=11 and <12 years) | 114 Participants | — |
| Sex/Gender, Customized Female (<=6 and <7 years) | 2 Participants | — |
| Sex/Gender, Customized Female (<=7 and <8) | 10 Participants | — |
| Sex/Gender, Customized Female (<=8 and <9 years) | 17 Participants | — |
| Sex/Gender, Customized Female (<=9 and <10 years) | 21 Participants | — |
| Sex/Gender, Customized Male (<=10 and <11 years) | 16 Participants | — |
| Sex/Gender, Customized Male (<=11 and <12 years) | 37 Participants | — |
| Sex/Gender, Customized Male (<=6 and <7 years) | 1 Participants | — |
| Sex/Gender, Customized Male (<=7 and <8 years) | 1 Participants | — |
| Sex/Gender, Customized Male (<=8 and <9 years) | 9 Participants | — |
| Sex/Gender, Customized Male (<=9 and <10 years) | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 293 |
| other Total, other adverse events | 0 / 293 |
| serious Total, serious adverse events | 0 / 293 |
Outcome results
Primary
Rate of Device Related Adverse Events
Incidence of device-related adverse events reported by subjects throughout the study period
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-adolescence With Migraine | Rate of Device Related Adverse Events | 0 Participants |
Secondary
Consistent Freedom From Headache at 2 Hours Post-treatment
The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later
Time frame: up to 6 months
Population: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-adolescence With Migraine | Consistent Freedom From Headache at 2 Hours Post-treatment | 9 Participants |
Secondary
Consistent Functional Disability Disappearance at 2 Hours Post-treatment
The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.
Time frame: up to 6 months
Population: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-adolescence With Migraine | Consistent Functional Disability Disappearance at 2 Hours Post-treatment | 7 Participants |
Secondary
Consistent Functional Disability Relief at 2 Hours Post-treatment
The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.
Time frame: up to 6 months
Population: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-adolescence With Migraine | Consistent Functional Disability Relief at 2 Hours Post-treatment | 15 Participants |
Secondary
Consistent Headache Relief at 2 Hours Post-treatment
The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.
Time frame: up to 6 months
Population: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-adolescence With Migraine | Consistent Headache Relief at 2 Hours Post-treatment | 13 Participants |
Secondary
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
The proportion of subjects reporting the presence of each of the migraine-associated symptoms (nausea/vomiting, photophobia, phonophobia) at the beginning of treatment and reported their absence 2 hours following the treatment in at least 50% of their attacks.
Time frame: up to 6 months
Population: Patients at the age of 6-11 (included) who used the Nerivio device and had at least 2 pre and post treatments reports were included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-adolescence With Migraine | Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment | Nausea/vomiting | 7 Participants |
| Pre-adolescence With Migraine | Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment | Photophobia | 2 Participants |
| Pre-adolescence With Migraine | Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment | Phonophobia | 4 Participants |
| Pre-adolescence With Migraine | Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment | At least one symptom | 7 Participants |