The RECLAIM Study.

Salvia BioElectronics

Status: Enrolling

Conditions: High Frequency Episodic Migraine; Chronic Migraine

Treatments: Device: PRIMUS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06450444

SCI-03-RM

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
• Failure of 3 or more preventive pharmacological therapies
• Stable on preventive migraine treatments
• Psychologically stable

Exclusion criteria

• Concomitant invasive or non-invasive neuromodulation
• Previous exposure to an implantable neuromodulation device for headache
• Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)
• Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
• Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.
• Not pregnant, nursing or not using contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 4 patient groups

Cohort 1 - Treatment Group

Experimental group

Description:

Active therapy modality

Treatment:

Device: PRIMUS

Cohort 1 - Control Group

Other group

Description:

Sham therapy

Treatment:

Device: PRIMUS

Cohort 2 - Therapy V

Experimental group

Description:

Active therapy modality

Treatment:

Device: PRIMUS

Cohort 2 - Therapy D

Experimental group

Description:

Active therapy modality

Treatment:

Device: PRIMUS