Using virtual reality and brain stimulation to help cancer patients with depression
Cost-effectiveness of Transcranial Magnetic Stimulation and Virtual Reality Based Cognitive Remediation on Depressive Symptoms Among Cancer Patients: a Three-arm Randomized Clinical Trial.
This study is testing whether using virtual reality and brain stimulation can help cancer patients with depression feel better compared to regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 2 sites (Ferrara, FE and 1 other locations) |
| Trial ID | NCT06589544 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of non-pharmacological interventions, specifically virtual reality-based cognitive remediation and repetitive transcranial magnetic stimulation, in treating depression among cancer patients. It aims to address the significant gaps in managing depressive symptoms in oncology patients, who often go untreated despite their needs. The study will compare these innovative approaches to standard treatment as usual, assessing their impact on depressive symptoms, cognitive function, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with cancer within the last five years and are experiencing major depressive disorder without psychotic symptoms.
Not a fit: Patients with severe vision impairments, significant neurological disorders, or those who are currently hospitalized or have planned surgeries in the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and effective treatment option for cancer patients suffering from depression, improving their mental health and quality of life.
How similar studies have performed: While emerging strategies like rTMS and cognitive rehabilitation show promise, the specific combination of virtual reality and rTMS in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of oncological disease in the last 5 years * Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria * 17-item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14) * Age: 18 years or older * Oncological disease in a non-advanced stage (Karnofsky Performance Status \> 80) Exclusion Criteria: * Current or prior hospitalization in the next 6 months * Planned surgery in the next 6 months * Suicidal ideation * Substance use * History of significant head trauma, neurological disorders, intellectual deficits * Recurrent seizures resulting from head trauma or conditions lowering seizure threshold * Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline) * Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology * Severe problems with autonomous ambulation
Where this trial is running
Ferrara, FE and 1 other locations
- Health Trust, Ferrara — Ferrara, Fe, Italy (Recruiting)
- University Hospital of Cagliari — Cagliari, Italy (Recruiting)
Study contacts
- Principal investigator: Luigi Grassi, MD, PhD — Università degli Studi di Ferrara
- Study coordinator: Martino Belvederi Murri, MD
- Email: martino.belvederimurri@unife.it
- Phone: 00393335248720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.