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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07191392
Enrollment
60
Registered
2025-09-24
Start date
2025-09-01
Completion date
2026-06-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Temporal Interference Stimulation

Brief summary

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

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.

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.

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

Sponsors

The Second Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 60 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
face-word assciative memory task scorebaseline and immediately after the interventionIn 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.
Change in Hamilton Depression Rating Scale (HAMD) Scorebaseline and immediately after the interventionThe 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.
Change in the Patient Health Questionnaire-15 (PHQ-15) scalebaseline and immediately after the interventionThe 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.

Secondary

MeasureTime frameDescription
MRI measuresbaseline and immediately after the interventionthe functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Dot-probe Taskbaseline and immediately after the interventionUsing 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.

Countries

China

Contacts

CONTACTYanghua Tian, PhD
zylykd@163.com0551 6599 7278

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026