Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS / Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) / Major Depressive Disorder (MDD) · Interventional Study

Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective registration for a multi-center double-blind RCT of temporal interference transcranial alternating current stimulation targeting the amygdala in major depressive disorder. The study has not yet begun recruitment and no results are available. The protocol describes a 2-week treatment phase with 20 sessions and follow-up to 6 months, using HAMD-17 change as the primary outcome.

What was studied

Interventional, Randomized, Parallel, Double masking, Treatment purpose. Major Depressive Disorder (MDD); age from 18 Years; to 55 Years. Intervention: High-frequency TI-tACS; Low-frequency TI-tACS. Compared with: Sham TI-tACS — Sham Comparator. n = 102. Multi-center (specific sites not listed in this registry extract)..

Key findings

Safety

Secondary outcomes (changes in clinical symptoms, cognitive function, safety profiles) are mentioned but not defined quantitatively in the registry.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a trial registration for a planned interventional study with no results reported; enrollment has not yet begun, making it a prospective protocol document only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2. (assessed at 2 weeks(from baseline))

DesignInterventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationMajor Depressive Disorder (MDD); age from 18 Years; to 55 Years

Sample size102

InterventionHigh-frequency TI-tACS; Low-frequency TI-tACS

ComparatorSham TI-tACS — Sham Comparator

SettingMulti-center (specific sites not listed in this registry extract).

Reported figures

Quoted from the source exactly as published.

Planned sample size102

Primary outcome measureChange from baseline in Hamilton Depression Rating Scale (HAMD-17) at week 2

Intervention armsHigh-frequency TI-tACS (130 Hz), low-frequency TI-tACS (2 Hz), sham stimulation

Treatment duration20 sessions over 2 weeks (twice daily for 5 consecutive days, 2-day break, 5 consecutive days)

Follow-up periodUp to 6 months

Caveats

This is a registry record only; no results are reported and recruitment has not yet begun.
Power calculation or sample size justification not provided in the registry document.
Specific eligibility criteria, site locations, and detailed allocation concealment methods are not stated in this extract.
Secondary outcomes (changes in clinical symptoms, cognitive function, safety profiles) are mentioned but not defined quantitatively in the registry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Multi-center, double-blind, randomized controlled trial planned; no results yet available.

Directness

moderate

Primary outcome is HAMD-17 change at week 2; clinically relevant but short follow-up window.

Consistency

insufficient

No results reported; consistency cannot be assessed from this registry record.

Risk of bias

moderate

Double-blind, randomized design mitigates bias; sham control present; no reporting of allocation concealment detail.

Sample adequacy

insufficient

Estimated 102 participants across three arms; power calculation or justification not stated in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07712159). This is a study registration, not published results. Lead sponsor: Central South University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 102 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD). Interventions: DEVICE: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS); DEVICE: Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS). Primary outcome measures: Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2. , 2 weeks(from baseline). Brief summary: This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD) Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala. The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months. The primary outcome for MDD is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACSNCT07712159Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)Central South UniversityMajor Depressive Disorder (MDD)