Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) in the Treatment of Adolescent Depression

March 28, 2025 updated by: Xijing Hospital
This trial is a single-center, single-blind, randomized, sham-stimulation controlled clinical trial. The primary objective of the trial is to detect the targeted effect of tTIS on the nucleus accumbens of adolescent depression patients using functional magnetic resonance imaging (MRI). The secondary objective is to evaluate the potential therapeutic efficacy of TIS treatment for adolescent MDD by assessing changes in clinical characteristics of participants, electrophysiological outcomes, and providing feasibility and tolerance estimates for large-scale efficacy trials. Thirty adolescent MDD participants aged 13 to 17 will be recruited and randomly assigned to receive 10 TIS treatments or sham stimulation treatments (15 participants per group). The trial includes pre-treatment and post-treatment MRI brain scans, clinical assessments, and resting-state EEG, fNIRS acquisition. Follow-ups will be conducted at baseline, after the 10th day of treatment, at the 4th week, and the 8th week. The Montgomery-Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HAMD-17), and the Self-Rating Depression Scale (SDS) will be used to assess changes in depressive symptoms of the subjects. The Hamilton Anxiety Rating Scale (HAMA) and the Self-Rating Anxiety Scale (SAS) will be used to assess anxiety symptoms of the subjects. The Wechsler Adult Intelligence Scale-Revised China (WAIS-RC) will be used to assess cognitive function of the subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Age 13 - 17 years old; 2)Meet the DSM-5 criteria for MDD with a current MDE without psychotic features, as confirmed by the MINI 3) HAMD-17 total score of ≥20 4) No change in treatment regimen in the 4 weeks prior to screening 5) No severe mental disorders or intellectual disabilities; 6)Can cooperate actively with the experimental process and subsequent follow-up.

Exclusion Criteria:

  • 1) serious diseases such as heart, liver, kidney and hematopoietic system disorders; 2) abuse drugs or are addicted to alcohol or suffer from uncontrollable mental illnesses; 3) Active suicidal intent, confirmed by the MINI Module B (Suicidality) or HAMD-17 item #3 score ≥3; 4) Pregnant or lactating; 5) Those who have identified definite organic lesions such as infarction foci, softening foci, hemorrhage foci, and space-occupying lesions through plain scan of cranial MRI; 6) Those with implanted objects in the brain (such as aneurysm clips, shunt devices, stimulators, cochlear implants or electrodes) or any other metal objects in or near the head, and cannot be safely removed; 7) Change in medication or psychotherapy treatment regimen before screening 8) Could not cooperate with fMRI examination or tTIS treatment; 9)Have received other forms of brain stimulation treatment in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tTIS Group
This group received 10 sessions of tTIS treatment, once a day, each session lasting approximately 30 minutes.
Device: Transcranial temporal interference stimulation
Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain. The physics of tTIS offers the advantage of non-invasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
Other Names:
  • tTIS
Sham Comparator: Sham group
This group will receive 10 sessions of sham tTIS treatment, once a day, each session lasting approximately 30 minutes.
Device: sham tTIS
The sham tTIS is enabled by checking the "Pseudo-Stimulation" option on the screen. After the rising phase, the current will drop directly to 0mA, imitating the sensation of a real stimulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in Montgomery-Asberg Depression Rating Scale (MADRS) between groups overtime
Time Frame: baseline, 10 days, 28 days, 56 days
The change in Montgomery-Asberg Depression Rating Scale (MADRS) between groups overtime
baseline, 10 days, 28 days, 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20242385

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings