Randomized, Double-blind, Sham-controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine.

Chronic Migraine Clinical Trial

— RECLAIM  

Official title:

Randomized, Double-blind, Sham-controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450444
• Other study ID #: SCI-03-RM
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 24, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: June 2024
• Source: Salvia BioElectronics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: February 1, 2027
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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 steroid infiltrations or IV administration in the past 3 months.
• Not pregnant, nursing or not using contraception

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• PRIMUS
The Salvia PRIMUS Peripheral Nerve Stimulation (PNS) System (System) is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

Locations

Country	Name	City	State
Belgium	AZ Delta	Roeselare
Belgium	GZA Ziekenhuizen	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Salvia BioElectronics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation	The incidence of serious procedure, device and/or stimulation-related adverse events.	12 weeks
Primary	Effectiveness Evaluation	Difference between randomization arms, in proportion of subjects with = 30% reduction in the number of Monthly Migraine Days (MMD).	12 weeks