Neurostimulation Device for Treatment of Migraine Headache

NCT ID: NCT01630044

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-04-30

Brief Summary

This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.

Conditions

Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

TNM device, active treatment

This is an active-only assessment of the experimental neuromodulation device

Group Type: EXPERIMENTAL

TNM device

Intervention Type: DEVICE

Non-invasive neurostimulator, home-use treatment for up to 43 days.

Interventions

TNM device

Non-invasive neurostimulator, home-use treatment for up to 43 days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
• A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
• The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
• Subject must be at least 18 years of age.

Exclusion Criteria

• Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
• A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scion NeuroStim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Laskowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Medicine / Neurology

Durham, North Carolina, United States

Countries

United States

References

Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.

Reference Type: BACKGROUND

PMID: 27777829 (View on PubMed)

Other Identifiers

Pro00037089

Identifier Type: -

Identifier Source: org_study_id