TCDS for the Treatment of Chronic Migraine

NCT07214454 | Not Yet Recruiting

• 1 other identifier: IRAS 361355
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Chronic Migraine Headache; Transcranial Direct Current Stimulation

Keywords

chronic migraine treatment; transcranial direct current stimulation; non-invasive neuromodulation

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Average number of participants enrolled per site per month

  1 year

• Adherence rate

  defined as the proportion of schedule transcranial direct current stimulation sessions completed by each participant

  12 weeks

• Data completeness

  defined as the proportion of days with a completed headache diary entry during the 12 week treatment phase

  12 weeks

Secondary Outcomes (13)

• 30% responder rate

  12 weeks

• Moderate to severe headache days

  12 weeks

• Headache Intensity

  12 weeks

• Adverse effects

  12 weeks

• Tolerability and usability

  12 weeks

Study Arms (1)

Treatment with transcranial direct current stimulation

EXPERIMENTAL

Patients will complete three months treatment of 20 minutes daily use of the Nettle device which delivers 2mA transcranial direct current stimulation to the primary motor cortex and the dorsolateral prefrontal cortex.

Device: Transcranial direct current stimulation (Nettle device) 2mA stimulation for 20 minutes per day

Interventions

Transcranial direct current stimulation (Nettle device) 2mA stimulation for 20 minutes per day DEVICE

The 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 with transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Manjit Matharu

CONTACT

020 3456 7890; manjit.matharu@nhs.net

Lucy Simmonds

CONTACT

lucysimmonds@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single site, feasibility study of transcranial direct current stimulation

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 9, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Beginning 12 months after the end point of the trial and ending 3 years after the publication of results.