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Could VR and a brain zapper lift Post-Stroke depression?
NCT ID NCT07422740
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining virtual reality mindfulness therapy with mild brain stimulation can help treat depression that occurs after a stroke. Researchers will enroll 120 adults aged 18-65 who had a stroke at least 4 weeks ago and have moderate to severe depression. Participants will be split into four groups to compare the combined treatment against each therapy alone or a placebo, with results tracked over 28 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- virtual reality mindfulness-based cognitive therapy and transcranial direct current stimulation
- What this could lead to
- If it works, this could offer a new, non-drug way to ease depression after a stroke, improving mood and daily function.
- What could go wrong
- This is an early-stage trial with only 120 people, so results may not apply to everyone. The combination therapy may not work better than standard care.
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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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 65 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: 1. Aged 18 to 65 years (inclusive). 2. Stroke onset ≥ 4 weeks, with stable condition and an NIHSS score ≤ 15. 3. Right-handed. 4. Patient must be in a depressive episode, defined by a PHQ-9 score ≥ 5 and confirmed by a HDRS-24 score ≥ 8. 5. Has not used any antidepressants before the enrollment. 6. No contraindications to tDCS (e.g., metal plates in the head, brain implants, aneurysm clips, cochlear implants, cardiac pacemakers, etc.). 7. Has not received systematic psychotherapy (such as MBCT, mindfulness training, or cognitive behavioral therapy) for the current or previous depressive episodes. 8. Has more than 8 years of formal education. 9. Has not received tDCS or other transcranial electrical stimulation treatment for the current or previous depressive episodes. 10. Is able to cooperate with multimodal MRI data collection and follow-up assessments, and can understand and comply with the study requirements. Exclusion Criteria: 1. History of treatment-resistant depression, defined as failure to respond to at least two different antidepressant medications of adequate dosage and duration (at least 8 weeks at the maximum recommended therapeutic dose). 2. Other psychiatric diagnoses (e.g., intellectual disability, schizophrenia, affective psychosis, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, eating disorders, personality disorders, substance use disorders, post-traumatic stress disorder, panic disorder, or social phobia). Co-morbid anxiety disorder is acceptable. 3. Baseline Mini-Mental State Examination (MMSE) score ≤ 24. 4. Presence of suicidal ideation or plan within 4 weeks prior to baseline. 5. Depressive symptoms are better explained by another clinical condition (e.g., hypothyroidism, anemia, congestive heart failure) or other mental disorders. 6. Presence of severe, unstable cardiovascular, hepatic, renal, hematological, endocrine diseases, or malignancies. 7. Laboratory tests indicating significant impairment: total bilirubin (TBIL) \> 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times ULN; glomerular filtration rate (GFR) ≤ 70 mL/min; or thyroid-stimulating hormone (TSH) outside the normal range. 8. Poorly controlled hypertension (sitting systolic blood pressure (SBP) ≥ 180 mmHg or sitting diastolic blood pressure (DBP) ≥ 110 mmHg at screening or baseline). 9. Epilepsy and/or other neurological diseases (e.g., dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), or any neurological condition leading to increased intracranial pressure, brain damage, or increased risk of seizures. 10. Pregnant, lactating, or planning pregnancy. 11. Significant visual or hearing impairment that prevents participation in interventions or assessments. 12. Received brain stimulation therapy (e.g., ECT, mECT, TMS, rTMS, deep brain stimulation, vagus nerve stimulation) within 3 months prior to baseline. 13. Participation in another clinical trial within 1 month prior to baseline (excluding screening failures). 14. Any other condition deemed by the investigator as unsuitable for participation in the study.
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As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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