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Developing an Approach for Boosting the Effects of Transcranial Magnetic Stimulation in Major Depressive Disorder Using Synchronised Transcranial Electrical Stimulation ("tsTMS")
Sponsor study identifier
interventional
60
1 country
2
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 19, 2026
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in emotional bias (Cambridge Neuropsychological Test Automated Battery (CANTAB) Emotional Bias task)
Difference in shift of emotional bias between participants who receive five sessions of tsTMS (tACS + TMS) and participants who receive TMS alone (the two forms of tsTMS under study will be individually compared to TMS).
First measured at the baseline session (28 days within the first stimulation session), then measured at the fifth stimulation session, and finally repeated at the follow-up session (within 7 days +/- 3 days after the final, fifth stimulation session)
Frequency of adverse effects and tolerability
Total adverse effects score derived from the participant-completed adverse effects questionnaire administered after each stimulation session. The total score combines the frequency and severity of reported adverse effects.
After each of the five stimulation sessions.
Participant experience and acceptability
Participant perceptions of the acceptability and experience of receiving tsTMS or TMS with sham tACS and of participating in the study, assessed through a semi-structured qualitative interview.
Follow-up visit within 7 days (±3 days) after the fifth stimulation session
Change in task-related theta-frequency brain oscillatory activity
Stimulation Day 1. Pre-stimulation to post-stimulation (multiple timepoints at 5 min and 30 min post-stimulation) within the same session.
Change in Frontal Theta Power
Stimulation Day 1. Pre-stimulation to post-stimulation (multiple timepoints at 5min and 30min post-stimulation) within the same session.
Change in Central Beta Power
Stimulation Day 1. Pre-stimulation to post-stimulation (multiple timepoints at 5min and 30min post-stimulation) within the same session.
Change in Occipital Alpha Power
Stimulation Day 1. Pre-stimulation to post-stimulation (multiple timepoints at 5min and 30min post-stimulation) within the same session.
Change in Subjective Cognitive Difficulties (Perceived Deficits Questionnaire for Depression, 5-item version (PDQ-5-D))
Baseline and follow-up visit (within 7 days ±3 days after the fifth stimulation session).
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.
Mersey Care Mood Clinic at Knowsley Resource and Recovery Centre
Liverpool, L35 5DR, United Kingdom
Mersey Care Mood Clinic at Knowsley Resource and Recovery Centre
Liverpool, L35 5DR, United Kingdom
Briley PM, Boutry C, Webster L, Veniero D, Harvey-Seutcheu C, Jung J, Liddle PF, Morriss R. Intermittent theta burst stimulation with synchronised transcranial alternating current stimulation leads to enhanced frontal theta oscillations and a positive shift in emotional bias. Imaging Neurosci (Camb). 2024 Jan 25;2:imag-2-00073. doi: 10.1162/imag_a_00073. eCollection 2024.
First Submitted
August 24, 2026
First Posted
October 19, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2027
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-08
Individual participant data (IPD) collected during this study will not be made available to other researchers due to participant confidentiality, consent limitations, and data governance requirements.
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Source: ClinicalTrials.gov.
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