NCT07214454Toborzás még nem indult
TCDS for the Treatment of Chronic Migraine
An Open Label, Single-site Feasibility Study of Transcranial Direct Current Stimulation (tCDS), Using the Nettle Device, for the Treatment of Chronic Migraine.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 4.
Rövid összefoglaló (regiszter, angolul)
Migraine affects 1 in 7 people worldwide, but for those suffering from chronic migraine there is a need for safe, effective and well tolerated treatments. The Nettle device is a non-invasive device, which is worn like a headband and delivers electrical stimulation (known as transcranial direct current stimulation or TCDS) to areas of the brain known to be involved in the processing of pain. In this study, 20 patients will be trained on how to use the device and then use it daily at home for 20 minutes for three months. Patients will complete a headache diary and quality of life questionnaires before using the device, during and after. As this is a feasibility study, adherence to completing the diaries and questionnaires will be assessed. Compliance with the treatment paradigm will also be assessed.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2025. szept. 30.
- Kezdés
- 2026. febr. 1.
- Elsődleges befejezés
- 2026. jún. 1.
- Fő szponzor
- University College, London
- Betegségek
- Migrén
- NCT-szám
- NCT07214454
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 20
- 2026. febr. 1. és az elsődleges befejezés (2026. jún. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Implant inside skill, cochlear implant or implanted hearing aid.
- Concurrent medication overuse
- Use of cranial botulinum toxin injections or CGRP inhibitors in the past 6 months
- Planned surgical or significant medical intervention during the study period which may affect the study results, at the discretion of the chief investigator.
Más betegség
- Epilepsy or history of seizures
- Pre-existing neurological or neuropsychiatric condition
Egyéb
- Current or planned pregnancy during the study timeframe
- Active suicidal thoughts
- Lesion, tumour or other defect in skull or brain
- Implanted medical device e.g. pacemaker or neurostimulator
- Use of other stimulation devices such as spinal cord stimulators, vagal nerve stimulation, auricular nerve stimulator or deep brain stimulation.
- Current or recent (within three months) participation in another clinical trial.
- Lacking mental capacity to give informed written consent.
Kiket keres a vizsgálat
- Subjects aged 18-70 years
- Fulfil the International Classification of Headache Disorders -3 (ICHD-3) criteria for chronic migraine, diagnosed by a headache specialist, at least 1 year prior to entering the trial
- Subject is willing to keep headache medications stable for two weeks prior to entering the study and for the duration of the study.
- Access to a smart phone to use the mobile application to control the device and use the Headache Pro app to record headaches. A paper diary may be used instead of the Headache Pro app Id required by individual patients.
- Subject is able to provide written informed consent prior to participation in the study
- Females of childbearing potential agree to use an effective method of contraception from the time consent is signed until treatment discontinuation. Effective methods of contraception acceptable for this trial are the oral contraceptive pill, patch, implant, injection, ring, intra-uterine system, copper coil, barrier methods, partner vasectomy or abstinence. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- If there is any possibility of pregnancy, females of childbearing potential should have a negative pregnancy test within 7 days of commencing the treatment phase.
- Subject must be willing and able to provide written informed consent.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.