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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Transcranial direct current stimulation (Nettle device) 2mA stimulation for 20 minutes per day
DeviceThe Nettle device, manufactured by Samphire Neuroscience, contains four electrodes, two of which provide stimulation to the primary motor cortex (M1), and two stimulate the dorsolateral prefrontal cortex (DLPFC). A treatment session consists of 2mA stimulation for 20 minutes per day. Nettle is a Class IIa medical device which has a CE mark and is currently marketed for use in dysmenorrhoea and the mood component of premenstrual syndrome.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment with transcranial direct current stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Average number of participants enrolled per site per month
Time frame
1 year2
Adherence rate
defined as the proportion of schedule transcranial direct current stimulation sessions completed by each participant
Time frame
12 weeks3
Data completeness
defined as the proportion of days with a completed headache diary entry during the 12 week treatment phase
Time frame
12 weeksSecondary outcomes
1
30% responder rate
The proportion of patients achieving ≥30% reduction in monthly migraine days (30% responder rate)
Time frame
12 weeks2
Moderate to severe headache days
Mean change in monthly number of moderate to severe headache days
Time frame
12 weeks3
Headache Intensity
Mean change in monthly headache intensity (on a 0-10 visual analogue scale, with 0 being pain free and 10 being the most severe pain)
Time frame
12 weeks4
Adverse effects
Proportion of patients reporting device-related adverse events, with severity grading
Time frame
12 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: