Temporal Interference Stimulation Targeting Thalamus for Schizophrenia-Related Cognitive Dysfunction
Schizophrenia Disorder · Cognitive Impairments
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 80 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Prefrontal cortical dysfunction in patients with schizophrenia (SCZ) may result from impaired thalamic inputs to this region. Meanwhile, patients with SCZ exhibit a reduced GABA/glutamate ratio in the thalamus, indicating thalamic excitation/inhibition (E/I) imbalance. In addition, SCZ patients show marked reduction of sleep spindles, which are predominantly generated by the thalamic reticular nucleus. Therefore, thalamus-targeted temporal interference stimulation (TIS) may modulate the function of thalamocortical circuits, ameliorate clinical symptoms including cognitive deficits in patients with SCZ, and serve as an effective non-pharmacological intervention. This study consists of two trial components with three objectives: (1) to explore the therapeutic effect of TIS on cognitive function in patients with SCZ; (2) to explore the effect of TIS on positive symptoms in patients with SCZ; (3) to investigate the neural mechanisms underlying TIS-mediated symptom modulation in SCZ.
Trial 1: This study adopts a randomized, controlled, crossover design. Participants will be randomly assigned to two groups: Group A and Group B. Clinical data from 30 patients with schizophrenia (15 participants per group) will be collected, including baseline clinical rating scale scores, cognitive assessments, electroencephalography (EEG), and magnetic resonance imaging (MRI) data. All participants will receive two sessions of TIS intervention in a crossover fashion, with a 1-week washout period between the two interventions. One day prior to each TIS session, participants will complete two training runs of the Sternberg Item-Recognition Paradigm (SIRP) to eliminate confounding learning effects. Outcome measurements including clinical scale scores, cognitive assessments, EEG and MRI data will be acquired at baseline. Task-state MRI will be recorded during both stimulation sessions.
Trial 2: This trial uses a rigorous randomized controlled design. Participants will be randomized into two arms: the TIS group and the control group. Fifty patients with schizophrenia will be enrolled (25 participants per group). Baseline data will be collected, including clinical symptom ratings, cognitive function scores, EEG-derived E/I imbalance metrics, and MRI data. The intervention lasts for 2 weeks with twice-daily stimulation, totaling 20 sessions. Assessments will be performed at baseline, at the end of the 2-week intervention, and at a 4-week post-intervention follow-up to evaluate changes in clinical symptoms, cognition, EEG E/I imbalance, and brain structural and functional features. This trial aims to explore the short-term efficacy, safety, and neurobiological mechanisms of TIS for improving cognitive function in schizophrenia.
¿Quién podría participar?
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Inclusion Criteria:
- 18 to 60 years of age
- meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as confirmed by the \*Structured Clinical Interview for DSM-5\* (SCID-5)
- receiving 1 or 2 antipsychotic medications at a stable dose for at least 1 week before enrollment. Concurrent use of mood stabilizers, antidepressants, or excessive benzodiazepines (lorazepam \>2 mg/day) was prohibited，During treatment, the types of antipsychotic drugs remain the same, and the dosage adjustments should not exceed 25%.
- have functional impairment in daily activities
- provide written informed consent
- the disease duration does not exceed 8 years
- The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above
- At least one item of the Positive and Negative Syndrome Scale (PANSS) positive subscale has a score ≥ 4.
Exclusion Criteria:
- comorbid psychiatric disorders, intellectual disability, clinically significant mood symptoms, or substance use disorders (except caffeine or tobacco)
- a history of seizures, meningitis, or encephalitis
- contraindications to transcranial electrical stimulation
- intracranial tumors or prior neurosurgery
- a history of severe head trauma
- receipt of other transcranial electrical or magnetic therapies within 1 month before enrollment
- with clear drug-induced extrapyramidal reaction
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
Group A (A/S): Active stimulation first, followed by sham stimulation
Group A receives active stimulation in the first session and sham stimulation in the second session.One day prior to each TIS session, participants complete two training runs of the Sternberg Item-Recognition Paradigm (SIRP) to eliminate confounding learning effects.Electrodes are placed according to the 10-10 EEG system and secured with conductive paste.Stimulation is individualized based on each participant's Individual Alpha Frequency (IAF). Resting-state EEG is recorded before stimulation to determine the IAF. A continuous high-frequency sinusoidal current pair with a base frequency of 2000 Hz and a beat frequency tuned to the IAF is delivered through each electrode to generate pulsed stimulation for individualized iTBS.Electric field modeling based on T1-weighted MRI images is used to optimize personalized electrode montages, ensuring an electric field strength ≥ 0.2 V/m within the left thalamus for each participant.
Device: temporal interference stimulation · Device: Sham TIS
Group B (S/A): Sham stimulation first, followed by active stimulation
Group B receives sham stimulation in the first session and active stimulation in the second session.One day prior to each TIS session, participants complete two training runs of the Sternberg Item-Recognition Paradigm (SIRP) to eliminate confounding learning effects. Electrodes are placed according to the 10-10 EEG system and secured with conductive paste.Stimulation is individualized based on each participant's Individual Alpha Frequency (IAF). Resting-state EEG is recorded before stimulation to determine the IAF. A continuous high-frequency sinusoidal current pair with a base frequency of 2000 Hz and a beat frequency tuned to the IAF is delivered through each electrode to generate pulsed stimulation for individualized iTBS.Electric field modeling based on T1-weighted MRI images is used to optimize personalized electrode montages, ensuring an electric field strength ≥ 0.2 V/m within the left thalamus for each participant.
Device: temporal interference stimulation · Device: Sham TIS
sham group:Sham TIS
Participants in the sham group receive sham TIS following the identical schedule: two sessions daily for 10 days, 20 sessions in total. The sham paradigm uses the same 2000 Hz current pair. Current is only delivered during the 10-second ramp-up and ramp-down phases at the start and end of each session, while no current is applied during the middle period. This setup mimics the scalp tingling sensation induced by current changes at the beginning and end of active stimulation. All other hardware, electrode placement and study procedures are identical to the active TIS group.
Device: Sham TIS
TIS group:TIS
Participants in the TIS group receive active TIS stimulation, with two intervention sessions per day for 10 consecutive days, totaling 20 sessions. Each session lasts 30 minutes. Electrodes are placed according to the 10-10 EEG system and secured with conductive paste. Stimulation is individualized based on each participant's Individual Alpha Frequency (IAF). Resting-state EEG is recorded before stimulation to determine the IAF. A continuous high-frequency sinusoidal current pair with a base frequency of 2000 Hz and a beat frequency tuned to the IAF is delivered through each electrode to generate pulsed stimulation for individualized iTBS. Electric field modeling based on T1-weighted MRI images is used to optimize personalized electrode montages, ensuring an electric field strength ≥ 0.2 V/m within the left thalamus for each participant. Each stimulation session lasts 30 minutes, with a 10-second ramp-up period at the onset and a 10-second ramp-down period at the end.
Device: temporal interference stimulation
temporal interference stimulation DEVICE
Thalamus-targeted temporal interference stimulation delivered via Dome Medical TES NEURO-800, individualized based on individual alpha frequency with electric field optimization from T1 MRI.
Sham TIS DEVICE
Sham temporal interference stimulation with identical setup; current only delivered during brief ramp-up/ramp-down periods to mimic scalp sensation without effective thalamic stimulation.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Changes in brain function
Plazo: baseline (T1 structural scan); pre-, during, and post-first stimulation (Day 1); pre-, during, and post-second stimulation (Day 9)
Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.This outcome is for sub-trial 1 (single-session crossover TIS).
changes on the MATRICS Consensus Cognitive Battery (MCCB) scores
Plazo: baseline,2 week visit, 4-week follow-up visit
The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.This outcome is for sub-trial 2 (2-week repeated TIS).
Medidas secundarias
Changes in Positive and Negative Symptom Scale-6 (PANSS-6) scores
Plazo: pre-and post-first stimulation (Day 1); pre- and post-second stimulation (Day 9)
The PANSS-6 is a shortened version of the Positive and Negative Syndrome Scale for assessment of psychotic symptoms in schizophrenia. Scores range from 6 to 42, higher score indicates more severe psychotic symptoms. This outcome is for sub-trial 1 (single-session crossover TIS).
Change in brain responses during the Sternberg Item-Recognition Paradigm (SIRP)
Plazo: pre-, during, and post-first stimulation (Day 1); pre-, during, and post-second stimulation (Day 9)
The Sternberg Item-Recognition Paradigm (SIRP) is a task fMRI paradigm for evaluating working memory processing. T1-weighted structural MRI at baseline is acquired for individual brain modeling. Task fMRI scans are obtained pre-stimulation, during stimulation, and post-stimulation for each session. This outcome is for sub-trial 1 (single-session crossover TIS).
Changes in brain function
Plazo: baseline, 2-week visit (end of intervention)
Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in PANSS total scores
Plazo: baseline, 2-week visit (end of intervention), 4-week follow-up visit
The Positive and Negative Syndrome Scale (PANSS) is widely used to assess positive, negative and general psychopathology symptoms of schizophrenia. Scores range from 30 to 210, higher score indicates more severe positive and negative symptoms. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in PSYRATS scores
Plazo: baseline, 2-week visit (end of intervention), 4-week follow-up visit
The Psychotic Symptoms Rating Scale (PSYRATS) quantifies the severity and dimensional features of hallucinations and delusions in patients with psychosis. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in SANS scores
Plazo: baseline, 2-week visit (end of intervention), 4-week follow-up visit
The Scale for the Assessment of Negative Symptoms (SANS) evaluates the severity of negative symptoms in schizophrenia, including affective flattening, alogia, avolition-apathy, anhedonia-asociality and attentional impairment. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in GAF scores
Plazo: baseline, 2-week visit (end of intervention), 4-week follow-up visit
The Global Assessment of Functioning (GAF) scale rates overall psychological, social and occupational functioning. Scores range from 0 to 100, higher score represents better functional status. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in Global Functioning Scale (GFS) scores
Plazo: baseline, 4-week follow-up visit
The Global Functioning Scale (GFS) assesses real-world social and role functioning among individuals with severe mental disorders. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in Social Functioning Scale (SFS) scores
Plazo: baseline,4-week follow-up visit
The Social Functioning Scale (SFS) measures multiple domains of social functioning for patients with schizophrenia spectrum disorders. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in brain responses during the 2-back task fMRI paradigm
Plazo: 2-week visit (end of intervention)
Task fMRI based on the 2-back working memory paradigm used to assess working memory-related thalamocortical brain activity. High-resolution T1-weighted structural MRI at baseline is acquired for individual brain modeling. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in 1/f aperiodic EEG signal (E/I balance index)
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
The 1/f aperiodic signal of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance. This outcome is for sub-trial 2 (2-week repeated TIS).This outcome is for sub-trial 2 (2-week repeated TIS).
Change in long-range temporal correlation (LRTC) of resting EEG
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
Long-range temporal correlation (LRTC) of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in functional E/I ratio (fE/I) of resting EEG
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
Functional E/I ratio (fE/I) from resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in gamma oscillatory power of resting EEG
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
Gamma-band oscillatory power of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in beta oscillatory power of resting EEG
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
Beta-band oscillatory power of resting-state electroencephalography is measured as an index of excitation-inhibition (E/I) balance.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in 40 Hz auditory steady-state response (40 Hz-ASSR)
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
40 Hz auditory steady-state response (40 Hz-ASSR) is recorded by electroencephalography for excitation-inhibition balance assessment.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in mismatch negativity (MMN) amplitude
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
Mismatch negativity (MMN) is recorded by electroencephalography for excitation-inhibition balance assessment.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in P50 sensory gating ratio
Plazo: baseline, after first stimulation,2-week visit (end of intervention), 4-week follow-up visit
P50 sensory gating ratio is recorded by electroencephalography for sensory gating assessment.This outcome is for sub-trial 2 (2-week repeated TIS).
Sleep spindle density from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Sleep spindle density is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Sleep spindle frequency from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Sleep spindle frequency is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Sleep spindle amplitude from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Sleep spindle amplitude is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Sleep spindle duration from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Sleep spindle duration is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Slow oscillation power from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Slow oscillation power is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Slow oscillation amplitude from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Slow oscillation amplitude is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Slow oscillation slope from sleep EEG
Plazo: baseline, 2-week visit (end of intervention)
Slow oscillation slope is derived from sleep electroencephalography.This outcome is for sub-trial 2 (2-week repeated TIS).
Change in routine blood test parameters
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for routine blood examination. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in liver function parameters
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for liver function testing. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in renal function parameters
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for renal function testing. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in blood lipid levels
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for blood lipid testing. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in fasting plasma glucose concentration
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for fasting glucose testing. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
Change in peripheral inflammatory factor concentrations
Plazo: baseline, 4-week follow-up visit
Approximately 10 mL of intravenous blood is collected (2 mL whole blood, 4 mL serum, 4 mL plasma) at baseline and 4-week follow-up. Samples are sent to the clinical laboratory of the Second Xiangya Hospital, Central South University for inflammatory factor testing. Samples are destroyed immediately after testing, and test data are limited for use by the Second Xiangya Hospital, Central South University. This outcome is for sub-trial 2 (2-week repeated TIS).
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Second Xiangya Hospital, Central South UniversityChangsha, Hunan, ChinaEstado desconocido
Equipo y fechas
- Patrocinador principal
- Central South University
- Inicio del estudio
- 2026-11 Estimado
- Finalización primaria
- 1 oct 2027 Estimado
- Finalización del estudio
- 31 oct 2027 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Therapeutic Efficacy and Mechanism of Temporal Interference Stimulation on Thalamic-Mediated Cognitive Impairment in Schizophrenia
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Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026