Deep brain stimulation for treating apathy in frontotemporal dementia
Subgenual Cingulate Deep Brain Stimulation for Apathetic Behavioral Variant Frontotemporal Dementia - A Pilot Trial
This study is testing if deep brain stimulation can help people with frontotemporal dementia who feel apathetic by improving their brain function and reducing their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05699330 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of bilateral deep brain stimulation (DBS) of the subgenual cingulate in patients diagnosed with apathetic behavioral variant frontotemporal dementia (abvFTD). The study will monitor intraoperative and postoperative adverse events while assessing the physiological and clinical effects of DBS through neuroimaging and neuropsychological testing. Investigators hypothesize that DBS will enhance brain activity in dysfunctional circuits associated with abvFTD, potentially alleviating symptoms such as apathy and loss of executive function.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 40-85 with a diagnosis of behavioral variant frontotemporal dementia and apathy as a symptom.
Not a fit: Patients with other major psychiatric diagnoses or significant central nervous system diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from apathy due to frontotemporal dementia.
How similar studies have performed: While deep brain stimulation has been explored in other neurological conditions, this specific application for apathetic behavioral variant frontotemporal dementia is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women aged 40-85 years 2. Diagnosis of image-supported behavioral variant frontotemporal dementia according to NIC-FTD and NACC FTLD guidelines 3. Apathy as one of the symptoms 4. Stable dose of baseline FTD medications for at least 3 months 5. The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function. The patient must also have a substitute decision maker, if different from caregiver, to sign the informed consent for participation in the study. Exclusion Criteria: 1. Meets diagnostic criteria for other psychiatric diagnosis 2. Has other major Central Nervous System (CNS) disease that impairs motor, sensory or cognitive 3. Alcohol or illegal substance dependence within last 12 months 4. Other medical conditions which render anesthesia and surgery as unsafe as determined by neurosurgeon 5. Contraindications for MRI scanning, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces. 6. Has a medical condition requiring a repetitive MRI body scan 7. Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous (immunosuppressive or) steroid therapy 8. Is unable to comply with study visit schedule and timeline 9. Past significant intracranial surgery 10. A female lactating or of child-bearing potential, with a positive pregnancy test or not using adequate contraception.
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Andres M Lozano, MD, PhD — University Health Network, Toronto
- Study coordinator: Cletus Cheyuo, MD, PhD
- Email: cletus.cheyuo@uhn.ca
- Phone: 6478076845
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.