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

NCT07191392 | Recruiting DMC

• 1 other identifier: AHMU-TIS-MDD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depressive Disorder; Temporal Interference Stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline and immediately after the intervention

• 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.

  baseline and immediately after the intervention

• 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.

  baseline and immediately after the intervention

Secondary Outcomes (2)

• MRI measures

  baseline and immediately after the intervention

• Dot-probe Task

  baseline and immediately after the intervention

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Participants will receive active TIS 10 to 14 times.

Device: Temporal Interference Stimulation (TIS)

sham stimulation

SHAM COMPARATOR

Participants will receive sham TIS 10 to 14 times.

Device: Sham temporal interference stimulation (TIS)

Interventions

Temporal Interference Stimulation (TIS) DEVICE

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.

real stimulation

Sham temporal interference stimulation (TIS) DEVICE

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

sham stimulation

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (2)

Anhui Medical University

Hefei, Anhui, China

RECRUITING

Anhui Mental Health Center

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Central Study Contacts

Yanghua Tian, PhD

CONTACT

0551 6599 7278; zylykd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Anhui Medical University

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-12

Locations

CN (2)