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Could VR and a brain zapper lift Post-Stroke depression?

NCT ID NCT07422740

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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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