NCT07087678Toborzás még nem indult
Occipital Nerve Stimulation in Chronic Migraine
A Prospective, Randomised, Open Label Feasibility Trial Comparing BurstDR Microdosing Versus Tonic Occipital Nerve Stimulation for Patients With Refractory Chronic Migraine
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 28. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to compare two different types of occipital nerve stimulation (BurstDR (dorsal root) microdosing versus Tonic) in chronic refractory migraine. The main questions it aims to answer is whether BurstDR microdosing is effective in reducing moderate to severe headache days compared to Tonic stimulation (which is currently in use). Additionally, the safety of both types of stimulation will be studied. Participants will be asked to keep a headache diary, then have the device implanted and programmed, and keep a subsequent headache diary to see if there is an improvement in their headaches after three moths of stimulation. If they don't respond to treatment, they will be allowed to swap to the other type of stimulation to see if this improves their symptoms.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2025. ápr. 30.
- Kezdés
- 2025. szept. 1.
- Elsődleges befejezés
- 2027. jún. 1.
- Fő szponzor
- University College, London
- Betegségek
- Migrén
- NCT-szám
- NCT07087678
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 40
- 2025. szept. 1. és az elsődleges befejezés (2027. jún. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to, an investigational drug or device, except for sponsor-related studies.
- Subject has medication overuse headache which has not been managed (by withdrawal of the causative medication).
Más betegség
- Subject has clinically significant drug (including opioid) or alcohol abuse as defined by DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision), will likely be unable to refrain from substance abuse throughout the study, has another significant pain problem, substance abuse or active depressive episode that might confound the study assessments in the opinion of the Investigator.
- Subject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP (glycoprotein) IIb IIIa inhibitor medication in preparation for the implantation procedure.
Életkor
- Subject's overall health, age and/or comorbidities place subject at high risk for complications from surgery and/or general anaesthesia.
Egyéb
- Subject is felt to be at risk of non-compliance (e.g., for completing the diary/questionnaires or returning for required follow-up visits) in the Investigator's opinion.
- Subject is a woman of childbearing potential who is pregnant, nursing, or not using effective contraception.
- Subject has an active implantable device such as pacemaker/ defibrillator or other neurostimulation device.
- Subject is not suitable for the study for any reason in the judgment of the Investigator.
Kiket keres a vizsgálat
- Age ≥ 18 years old and diagnosed with intractable chronic migraine by a headache specialist, as defined by the International Classification of Headache Disorders-3 (ICHD-3).
- Subject should have failed to gain benefit from at least 4 classes of oral preventative medications, Botulinum toxin or acupuncture as defined by NHS (National Health Service) England Subject has been diagnosed at least 6 months prior to study enrolment with migraine headache with or without aura according to the ICHD-3 criteria 1.1, 1.2.1, or 1.3.
- Subject is able to distinguish migraine attacks from other headaches (e.g. tension type headache, cluster headaches).
- Subject agrees to not participate in supplemental or alternative therapy through the Follow Up Period of the study. This includes acupuncture, spinal manipulation, TENS (transcutaneous electrical nerve stimulation), and magnetic fields treatments.
- Subject has the ability to read, comprehend, and to reliably record information as required by the Protocol.
- Subject is able to provide written informed consent prior to participation in the study.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.