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Temporal Interference Stimulation (TI) for Schizophrenia (SCZ)
Sponsor: Anhui Medical University
Summary
This study will evaluate whether temporal interference (TI) stimulation, added to usual clinical treatment, improves symptoms of schizophrenia and is safe and tolerable. Approximately 100 adults aged 18 to 60 years with schizophrenia will be randomly assigned in equal numbers to active TI or sham TI. Participants and researchers assessing treatment outcomes will not know which treatment has been assigned. Participants will continue usual clinical treatment and receive two 30-minute stimulation sessions daily for 14 consecutive days, for a total of 28 sessions. Symptoms will be assessed before treatment and on Days 7, 15, and 45. Magnetic resonance imaging (MRI) scans will be obtained before treatment and on Day 15. Side effects will be monitored throughout participation. The main question is whether active TI produces a greater improvement in overall schizophrenia symptoms from baseline to Day 15 than sham TI. The study will also assess symptom improvement at other time points, changes in other symptoms, treatment completion, safety, and changes in brain imaging measures.
Official title: Efficacy and Safety of Temporal Interference Stimulation for Schizophrenia: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-11-01
Completion Date
2027-12-20
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Active transcranial temporal interference stimulation
Two pairs of scalp electrodes will deliver sinusoidal alternating currents at carrier frequencies of 2000 Hz and 2005 Hz, producing a 5-Hz modulation frequency at the modeled left-insula target. Electrode positions, channel configuration, and current amplitudes will be individualized using MRI-based finite-element modeling. The current amplitudes and their ratio will be set according to the individualized electric-field modeling results, allowing unequal amplitudes between channels. Current settings and actual outputs will be recorded for each session. Each session will last 30 minutes, with 30-second ramp-up and ramp-down periods at the beginning and end, respectively. Two sessions will be administered daily for 14 consecutive days, with at least 60 minutes between sessions, for a total of 28 sessions.
Sham transcranial temporal interference stimulation
Sham stimulation will use the same individualized electrode locations and channel configuration as active stimulation. The device will provide brief current at the beginning and end of each session, using 30-second ramping procedures to mimic scalp sensations, but will not deliver sustained treatment current during the middle of the session. Session duration, treatment schedule, monitoring, device displays, and communication procedures will match those used in the active arm.
Locations (1)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China