Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine

NCT05804396 | Withdrawn FDA Device

• 1 other identifier: SP-303-PERL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The PERL Study will evaluate the safety and efficacy of a self-administered preventive treatment for migraine headache using combined occipital and trigeminal nerve stimulation (Relivion®). This is a prospective, non-randomized, single arm, multi-center study designed to evaluate the use of Relivion® in reducing the frequency of headache days against a sham performance goal.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Mean change in Monthly Migraine Days (MMD).

  Mean change from baseline (M0) in Monthly Migraine Days (MMD) comparing with the last 28 treatment days (M3: weeks 9-12).

  3 months

Secondary Outcomes (3)

• Proportion of responder subjects

  3 months

• Mean change in monthly acute anti-migraine headache drug days.

  3 months

• Mean change total headache days.

  3 months

Study Arms (1)

Active stimulation

EXPERIMENTAL

Relivion® device- Active stimulation

Device: Relivion®

Interventions

Relivion® DEVICE

Active stimulation device

Active stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age and older.
• Subject meets the ICHD-3 (2018) diagnostic criteria for either Episodic migraine (\<15 headache (HA) days/month) or Chronic (at least 15 days of HA/month with at least 8 days/month migraine days (migraine with and without aura) for \> 3 months).
• Subject migraine age of onset \<50 years of age.
• History of 6 to 24 headache days on average per month for the 3 months preceding study enrolment (based on participant report).
• Completed at least 21 out of 28 days in the eDiary during run-in period. Partially completed data for the run-in period will be adjusted to reflect an estimated number of days with the outcome of interest per 28-day interval by using the formula (28/x)\*y, where x is the number of days with observed data per 28-day period and y is the number of observed days with the outcome of interest.
• Subject reports 6-24 headache days per 28 days, confirmed by 28 days or adjusted 28 days baseline diary.
• Subjects on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the screening visit, and the dose is not expected to change during the course of the study.
• Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent can complete the electronic diaries, and can be contacted by telephone.

You may not qualify if:

• Initiating or changing the type, dosage, or frequency of any medications for other indications than migraine that are determined to potentially interfere with the study.
• Failure on ≥2 well-conducted preventive treatments. A treatment failure (lack of efficacy) trial is characterized as a Level A or Level B evidence-based preventive treatment (medications or a MAB or preventive gepant) for migraine preventive trial taken for a minimum of 2 months, at a minimally adequate dose, that produced less than 50% improvement in MMD reduction). Failure to tolerate a preventive treatment does not constitute a preventive treatment failure.
• History of other chronic headache conditions such as Chronic tension-type headache, Medication Overuse Headache, New Daily Persistent Headache, and Cluster Headache in the prior 6 months.
• Use of opiates or barbiturates medications in the prior 3 months.
• Received parenteral infusions for migraine within the previous 2 weeks.
• Subject has known uncontrolled epilepsy.
• History of neuro-interventional procedures such as nerve blocks (within the last month), Botulinum Toxin (within the last 3-months), neurosurgical interventions in the head or neck, or implanted/wearable neurostimulators, electronic devices in the head, cardiac pacemaker, surgical clips above the shoulder line or medical pumps, except for dental implants.
• Current drug abuse or alcoholism.
• Subjects participating in other clinical trials evaluating experimental treatments or procedures.
• Skin lesion, scars, or inflammation in the region of the stimulating electrodes.
• Personality or somatoform disorder.
• Pregnancy or Lactation.
• Women of reproductive age not using a reliable contraceptive method, as determined by the Investigator (NOTE: Females of childbearing potential must have a negative pregnancy test).
• Documented history of cerebrovascular event.
• Subject with a recent history of traumatic brain injury (TBI), defined as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury, within 3 months of study enrollment.

Sponsors & Collaborators

• Neurolief Ltd.: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stewart J Tepper, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: November 24, 2024
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share