Could a zapping helmet lift bipolar depression?
NCT ID NCT07021508
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a non-invasive device that uses electrical fields to gently stimulate deep brain areas, aiming to improve depression in people with bipolar disorder. Researchers will compare the real device to a sham version in 160 adults. They will also use brain scans to understand how it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Temporal Interference Stimulation device
- What this could lead to
- If it works, this could offer a new, non-invasive way to reduce depression in people with bipolar disorder, without the side effects of medication.
- What could go wrong
- This is an early-stage study with no phase, so results are uncertain. The device may not work better than a sham (fake) treatment, and benefits may be small or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Psychiatry, First Affiliated Hospital of Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Brain wave patterns and inflammation: a clue to ECT's effectiveness in older adults?
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