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RELIEV-CM2 Pivotal Study

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A Pivotal Study Evaluating the Safety and Efficacy of the ShiraTronics Migraine Therapy System in RELIEVing, Interrupting, and Preventing Chronic Migraine (RELIEV-CM2)

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Device
  • Trial Phase: Phase III
  • Conditions Being Studied: Migraine

Study Purpose

A migraine is a burdensome, disabling headache, that involves attacks of throbbing, often on one side of the head, of moderate or severe pain, and worsened by physical activities. When a headache happens on at least 15 days each month with migraine on at least 8 days each month, and this pattern lasts for more than 3 months, it is considered chronic migraine. The purpose of this study is to demonstrate the safety and effectiveness of the ShiraTronics Migraine Therapy System. The ShiraTronics System was developed to manage RCM through neurostimulation. Neurostimulation produces small mild electrical pulses that interfere with the perception of pain signals. Pain signals normally travel from the source of pain along a nerve pathway to the brain. Applying the electrical pulses along the pathway disrupts or blocks the pain signals from migraine so that the signals will not be read as pain by your brain or reach your brain. Many people experience relief from different types of chronic pain using this method.

Who Can Participate

Age: 22 years and older

Principal Investigator
Salim Hayek MD PhD
Department/Division
Anesthesiology (Pain Management)

Locations

UH Ahuja Medical Center
3999 Richmond Road
Beachwood OH, 44122

UH Beachwood Medical Center
25501 Chagrin Blvd.
Beachwood OH, 44122

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: STUDY20240762
  • StudyID: 2024-01439
  • ClinicalTrials.gov: NCT06167655
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