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NCT06902064

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

Not yet recruiting NA Last updated 30 March 2025
What this trial tests

NA trial testing Transcranial temporal interference stimulation in Adolescent in 30 participants. Not yet recruiting.

Timeline
31 March 2025
Primary endpoint
31 December 2026
31 December 2027

Quick facts

Lead sponsorXijing Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date31 March 2025
Primary completion31 December 2026
Estimated completion31 December 2027

Drugs / interventions tested

Conditions studied

Sponsor

Xijing Hospital

Who can join

Adults 13 to 17, any sex, with Adolescent or Depression - Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Adolescent

Currently open trials in the same condition.

Other Xijing Hospital trials

Trials by the same sponsor.

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Data sources for this page

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