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NCT07879924

Dual Neuromodulation for Depression: Boosting TMS With tES

Sponsor: Mersey Care NHS Trust

View on ClinicalTrials.gov

Summary

Major depressive disorder (MDD) is a common and disabling condition. Transcranial magnetic stimulation (TMS) is an established non-invasive neuromodulation treatment for depression, but clinical response varies considerably between individuals. One possible reason for this variability is that the effects of TMS may depend on the pattern of ongoing brain activity at the time stimulation is delivered. This mechanistic, randomised, single-blind study will investigate whether synchronising TMS with transcranial alternating current stimulation (tACS), a form of weak electrical brain stimulation, can enhance the neurophysiological and cognitive effects of TMS in people experiencing a current moderate major depressive episode. The combined intervention is referred to as synchronised TMS (tsTMS). Up to 60 participants will be recruited and randomised in a 1:1:1 ratio to one of three groups: (1) TMS synchronised to the peak of a theta-frequency tACS waveform, (2) TMS synchronised to the trough of a theta-frequency tACS waveform, or (3) TMS combined with sham tACS. Participants will receive five daily neuromodulation sessions over one week. The primary objective is to estimate variability in change in emotional processing, measured using the Cambridge Cognition Emotional Bias Task, in order to inform the design and sample size calculation of a future clinical trial. The study will also assess participant acceptability and tolerability of the intervention. Secondary objectives include exploring changes in brain oscillatory activity measured using electroencephalography (EEG), cognitive performance, mood and anxiety symptoms, functional outcomes, and digital biomarkers collected from an optional wearable device. This study is designed to investigate mechanisms and feasibility rather than provide a full therapeutic course of TMS. Findings will be used to inform the development of a future definitive clinical trial evaluating whether synchronised neuromodulation can improve outcomes in depression.

Official title: Developing an Approach for Boosting the Effects of Transcranial Magnetic Stimulation in Major Depressive Disorder Using Synchronised Transcranial Electrical Stimulation ("tsTMS")

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-10-19

Healthy Volunteers

Conditions

Depression - Major Depressive Disorder

Interventions

DEVICE

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation intervention delivered using a magnetic coil positioned over the scalp to generate brief magnetic pulses that stimulate targeted cortical brain regions.

DEVICE

Transcranial Alternating Current Stimulation

Transcranial Alternating Current Stimulation (tACS) is a non-invasive neuromodulation intervention that delivers a weak alternating electrical current through electrodes placed on the scalp to modulate neural oscillatory activity in targeted brain regions.

Inclusion Criteria: 1. Adults aged 18-59 years old inclusive 2. Able to read and understand English 3. Capacity to provide informed consent to the study 4. PHQ-9 (Patient Health Questionnaire) score of 10-19 at screening 5. Meets criteria for a current major depressive episode (standardised SCID-RV interview) 6. Consents to researchers informing GP (and, if relevant, Local Mental Health Team) of study involvement Exclusion Criteria: 1. Currently under, or in need of, the care of mental health crisis (intensive home treatment) services 2. Current mood disorder with psychotic features (SCID-5-RV interview) 3. Current or past diagnosis of bipolar disorder, psychotic disorder, dementia, or mild cognitive impairment, or in the last twelve months alcohol/substance use disorder (SCID-5-RV interview) 4. PHQ-9 suicide item score of greater than one 5. MADRS suicide item score of greater than three 6. Diagnosis of epilepsy or previous seizures or suspected seizures (other than seizures associated with fever with none beyond age five) 7. Active significant skin conditions affecting the scalp, forehead or behind the ears (e.g. psoriasis) 8. Current known hearing problems or tinnitus 9. Cochlear implants, neurostimulators, pacemaker, intracardiac lines, infusion devices 10. Unremovable metal on head, neck or scalp (including unremovable hair extensions that contain metal, metallic piercings or red/orange/pink/yellow tattoos which may contain ferromagnetic dyes), or potential metal fragments in eyes 11. Known or suspected pregnancy (if, on the day, a participant is unsure, they will be given the option to rebook the testing session or to conduct a urine pregnancy test - however, they will be advised that pregnancy tests are only accurate from the first day of a missed period) 12. Medications judged to carry a significant increased risk of seizures 13. Allergies to substances in the tACS paste 14. Major unstable medical illness requiring further investigation or treatment 15. Changes in psychoactive medications in the two weeks preceding screening 16. Involvement in another clinical trial in the past three months, or current involvement in research study or trial that involves an intervention (medication, neuromodulation, psychotherapy)

Locations (2)

Mersey Care Mood Clinic at Knowsley Resource and Recovery Centre

Liverpool, United Kingdom