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RecruitingNCT07191392Updated Mar 10, 2026

Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder

An interventional study of Temporal Interference Stimulation (TIS) and Sham temporal interference stimulation (TIS) in Depressive Disorder and Temporal Interference Stimulation, sponsored by The Second Hospital of Anhui Medical University. Recruiting at 2 sites in China. Open to participants aged 12 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 60 Years
Sex
All
01

Study summary

To investigate the effect of Temporal Interference Stimulation (TIS) on associative memory (AM) in patients with depressive disorder

Read the detailed description

Depression group: thirty patients with depressive disorder diagnosed by DSM-5 were recruited from the Second Affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving TIS treatment. After meeting the inclusion criteria and obtaining informed consent. Each patient received either 30-minute or sham TIS.

Before and after the treatments, the patients had received a battery measure of neuropsychological tests, and MRI scan in multimodalities. Neuropsychological assessment included HAMD, ANSAQ, HAMA, PHQ15, BSSI, PSQI, ISI, RRS, Barratt,Buss\&Perry and PVAQ. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI.

Healthy controls: thirty healthy participants, who met the same exclusion criteria as the depressed patients but without a diagnosis of depression, were matched to the patients in terms of age, sex, and years of schooling.

The incidental memory task with emotional pictures were applied to evaluate the associative memory (AM) of thirty depressed patients at pre- and post-TIS compared to thirty healthy controls.

02

Conditions studied

  • Depressive Disorder
  • Temporal Interference Stimulation

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03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

The Second Hospital of Anhui Medical University is the lead sponsor of 28 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD>17, BSS>6, PHQ-15>5.
  • the age ranged from 18 to 65 years old, and the length of education was more than 5 years.
  • the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion criteria

Exclusion Criteria:

  • accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
  • accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
  • accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    real stimulation

    Participants will receive active TIS 10 to 14 times.

    Device: Temporal Interference Stimulation (TIS)

  • Sham comparator
    sham stimulation

    Participants will receive sham TIS 10 to 14 times.

    Device: Sham temporal interference stimulation (TIS)

Interventions

  • DeviceTemporal Interference Stimulation (TIS)

    The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.

  • DeviceSham temporal interference stimulation (TIS)

    Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation

06

What researchers measure

Primary outcomes

  1. face-word assciative memory task score

    In the face-cued word association test, participants viewed 12 grayscale photographs of faces on a computer screen, each shown for 4 seconds. Each photograph was paired with a distinct word, which participants read aloud when shown. Participants were instructed to memorize the word linked to each face. One minute later, participants viewed the same 12 faces in a new random order. They were then asked to recall the associated words. Each face was scored as correct or incorrect, and the total number of correct responses formed the AM score.

    Time frame: baseline and immediately after the intervention

  2. Change in Hamilton Depression Rating Scale (HAMD) Score

    The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.

    Time frame: baseline and immediately after the intervention

  3. Change in the Patient Health Questionnaire-15 (PHQ-15) scale

    The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.

    Time frame: baseline and immediately after the intervention

Secondary outcomes

  1. MRI measures

    the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.

    Time frame: baseline and immediately after the intervention

  2. Dot-probe Task

    Using the Chinese Affective Face Picture System, select 20 negative emotional faces, 20 positive emotional faces, and 40 neutral emotional faces, with an equal ratio of male and female faces. Match the positive and negative faces with neutral faces respectively. Run a standardized dot-probe paradigm using E-Prime software. First, a fixation point is displayed in the center of the screen for 1000 ms, followed by a pair of face images for 1000 ms-one emotional face and one neutral face. After the images disappear, a probe will randomly appear on either the left or right side. Press "A" for the left side and "L" for the right side. Record the participants' reaction time and accuracy in response to positive-neutral, neutral-neutral, and negative-neutral image pairs to evaluate attentional bias. Shorter reaction times and higher accuracy indicate higher scores.

    Time frame: baseline and immediately after the intervention

07

Study locations

2 of 2 sites recruiting
  • Anhui Medical University
    Hefei, Anhui, China
    Recruiting
  • Anhui Mental Health Center
    Hefei, Anhui, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07191392
Lead sponsor
The Second Hospital of Anhui Medical University
Responsible party
Yanghua Tian (Vice President of Anhui Medical University, The Second Hospital of Anhui Medical University) — Principal investigator
First posted
Sep 24, 2025
Start date
Sep 1, 2025
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

Yanghua Tian, PhD
Contact
zylykd@163.com
0551 6599 7278

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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