Zapping the Brain's fear center: a new hope for depression?
NCT ID NCT07059143
First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 4 times
Summary
This study tests a non-invasive device that uses gentle electrical currents to stimulate the right amygdala, a brain area linked to emotion. Fifty adults with major depression will receive either real or sham stimulation for six weeks. Researchers will measure changes in mood, thinking, and daily function to see if this approach can rapidly ease depressive symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nervio-X transcranial temporal interference stimulation (TIS) device
- What this could lead to
- If it works, this could offer a fast, non-drug option to relieve depression symptoms by targeting a specific brain area.
- What could go wrong
- This is a small early-stage trial with only 50 people, so results may not apply broadly. The device is experimental and its long-term safety and effectiveness are not yet proven.
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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38 people
The number who actually took part.
- Started
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May 2025
- Finished
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Jul 2026
- 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 60 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age : 18 to 60 years (inclusive), any gender. * Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes. * Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening. * Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using \>2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents\* ≥1 week prior to enrollment. * Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments. * Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent. Exclusion Criteria: * Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status) * Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems) * Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment * Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment * Concurrent Trials : Participation in other interventional clinical studies during the trial period * Reproductive Status : Pregnancy, lactation, or plans for conception during the trial * Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17) * Any condition deemed to compromise subject safety or study validity per clinical evaluation
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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.
Contacts and locations
Locations
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Anding Hospital (Mental Health Center of Tianjin Medical University)
Tianjin, China
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Ruijin Hospital
Shanghai, China
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The Affiliated Brain Hospital Of Guangzhou Medical University
Guangdong, China
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