NCT07191392

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Second Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Depressive Disorder
• Temporal Interference Stimulation

Interventions

Type	Name	Description
DEVICE	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	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-09-24
• Last updated: 2026-03-10

Locations

2 sites across 1 country: China