Status:
NOT_YET_RECRUITING
TCDS for the Treatment of Chronic Migraine
Lead Sponsor:
University College, London
Conditions:
Chronic Migraine Headache
Transcranial Direct Current Stimulation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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, w...
Detailed Description
This study is being performed in patients with chronic migraine (CM) which represents a significant burden to both individuals, but also the healthcare system and wider economy. Pharmacological option...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Epilepsy or history of seizures
- Current or planned pregnancy during the study timeframe
- Active suicidal thoughts
- Pre-existing neurological or neuropsychiatric condition
- Lesion, tumour or other defect in skull or brain
- Implant inside skill, cochlear implant or implanted hearing aid.
- 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.
- Concurrent medication overuse
- Use of cranial botulinum toxin injections or CGRP inhibitors in the past 6 months
- Current or recent (within three months) participation in another clinical trial.
- Planned surgical or significant medical intervention during the study period which may affect the study results, at the discretion of the chief investigator.
- Lacking mental capacity to give informed written consent.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07214454
Start Date
February 1 2026
End Date
June 1 2026
Last Update
December 4 2025
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