Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

Official title

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study

Overview

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.

Interventions

• Device Temporal Interference Stimulation
  A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.
• Device Sham Temporal Interference Stimulation
  The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.

Primary outcome measures

• Montgomery-Asberg Depression Rating Scale（MADRS） [Time frame: * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]

Secondary outcome measures (9)

• Hamilton Depression Scale（HAMD-17) [Time frame: * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Hamilton Anxiety Scale（HAMA） [Time frame: * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Young Mania Rating Scale（YMRS） [Time frame: * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Snaith-Hamilton Pleasure Scale（SHAPS） [Time frame: * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Temporal Experience of Pleasure Scale (TEPS) [Time frame: * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) [Time frame: * "Baseline" * "Day 1-5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Self-Rating Depression Scale (SDS) [Time frame: * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• Self-Rating Anxiety Scale (SAS) [Time frame: * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]
• THINC-integrated tool (THINC-it) [Time frame: * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation"]

Eligibility criteria

Inclusion criteria

• right-handed, and have completed nine years of compulsory education;
• Meet the diagnostic criteria for bipolar depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
• ≥18 points on the Hamilton Depression Inventory (HAMD- 17);
• ≤8 points on the Young's Mania Rating Scale (YMRS);
• Subjects who have not been treated with psychiatric medication, or those who have been treated with medication are required to undergo medication washout within 2 weeks before randomization;
• Subjects/legal guardians are willing to cooperate with the treatment and sign an informed consent form after they have fully understood the Temporal Interference Stimulation (TI).

Exclusion criteria

• Contraindications to magnetic resonance scanning (MRI) or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
• Prior or current electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), transcranial direct current therapy (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation;
• Pregnant and lactating women, and women of childbearing age with a positive urine pregnancy;
• Possesses a diagnosis of another major psychiatric disorder that has been assessed by the study investigator as a major disorder that results in more impairment than a diagnosis of bipolar disorder;
• Co-morbid other psychiatric disorders, including obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.; Has active suicidal ideation (≥ 4 points on item 10 of the MADRS);
• Risk of serious injury to self or others;
• History of serious physical illness or disease that may affect the central nervous system;
• Risk of neurologic disorders or seizures, such as previous craniosynostosis, cranial trauma, abnormal electroencephalograms, magnetic resonance evidence of structural abnormalities of the brain, or family history of epilepsy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Department of Psychiatry, First Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT07021508 · IIT20250009C-R1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗