Depressive DisorderNCT07191392
Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder
A study testing Temporal Interference Stimulation (TIS) in people with Depressive Disorder and Temporal Interference Stimulation, run by The Second Hospital of Anhui Medical University at 2 sites in China.
Trial summary
To investigate the effect of Temporal Interference Stimulation (TIS) on associative memory (AM) in patients with depressive disorder Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Temporal Interference Stimulation
- What is being tested?
- Temporal Interference Stimulation (TIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui
Yanghua Tian, PhD, 0551 6599 7278, ayfytyh@126.com
- Recruiting
Anhui Mental Health Center
Hefei, Anhui
Yanghua Tian, PhD, 0551 6599 7278, ayfytyh@126.com
About this study
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.
- Being tested
- Temporal Interference Stimulation (TIS), Sham temporal interference stimulation (TIS)
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | Participants will receive active TIS 10 to 14 times. Receives: Device: Temporal Interference Stimulation (TIS) |
| sham stimulation | Sham comparator | Participants will receive sham TIS 10 to 14 times. Receives: Device: Sham temporal interference stimulation (TIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline and immediately after the intervention
Secondary outcomes (2)
MRI measures
the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.
Measured: baseline and immediately after the intervention
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.
Measured: baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191392
- Sponsor's protocol ID
- AHMU-TIS-MDD
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder
- ClinicalTrials.gov ID
- NCT07191392
- Acronym / sponsor ID
- AHMU-TIS-MDD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Device: Temporal Interference Stimulation (TIS)Participants will receive active TIS 10 to 14 times. |
| sham stimulation | Sham comparator | Device: Sham temporal interference stimulation (TIS)Participants will receive sham TIS 10 to 14 times. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal 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. | Device | real stimulation |
| Sham 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 | Device | sham stimulation |
Primary outcome
face-word assciative memory task score
Time frame: baseline and immediately after the intervention
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.
Change in Hamilton Depression Rating Scale (HAMD) Score
Time frame: baseline and immediately after the intervention
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.
Change in the Patient Health Questionnaire-15 (PHQ-15) scale
Time frame: baseline and immediately after the intervention
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.
2 secondary outcomes
MRI measures
Time frame: baseline and immediately after the intervention
Dot-probe Task
Time frame: baseline and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation (TIS) in people with Depressive Disorder and Temporal Interference Stimulation, run by The Second Hospital of Anhui Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanghua Tian, PhD (0551 6599 7278, zylykd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
face-word assciative memory task score (time frame: baseline and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.