TCDS for the Treatment of Chronic Migraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Epilepsy or history of seizures
Current or planned pregnancy during the study timeframe
Active suicidal thoughts
Pre-existing neurological or neuropsychiatric condition
Trial design
Treatments tested in this trial
- Transcranial direct current stimulation (Nettle device) 2mA stimulation for 20 minutes per day
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov