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

NCT ID: NCT06902064

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Adolescent; Depression - Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tTIS Group

This group received 10 sessions of tTIS treatment, once a day, each session lasting approximately 30 minutes.

Group Type: EXPERIMENTAL

Transcranial temporal interference stimulation

Intervention Type: DEVICE

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.

Sham group

This group will receive 10 sessions of sham tTIS treatment, once a day, each session lasting approximately 30 minutes.

Group Type: SHAM_COMPARATOR

sham tTIS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

tTIS

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KY20242385

Identifier Type: -

Identifier Source: org_study_id