Subgenual Cingulate Deep Brain STIMulation for Apathetic Behavioral Variant FRONtotemporal Dementia (FRONSTIM)
Frontotemporal Dementia, Deep Brain Stimulation
About this trial
This is an interventional treatment trial for Frontotemporal Dementia focused on measuring Subgenual cingulate, Deep brain stimulation, Apathy, Behavioral variant
Eligibility Criteria
Inclusion Criteria: Men and women aged 40-85 years Diagnosis of image-supported behavioral variant frontotemporal dementia according to NIC-FTD and NACC FTLD guidelines Apathy as one of the symptoms Stable dose of baseline FTD medications for at least 3 months 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: Meets diagnostic criteria for other psychiatric diagnosis Has other major Central Nervous System (CNS) disease that impairs motor, sensory or cognitive Alcohol or illegal substance dependence within last 12 months Other medical conditions which render anesthesia and surgery as unsafe as determined by neurosurgeon 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. Has a medical condition requiring a repetitive MRI body scan Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous (immunosuppressive or) steroid therapy Is unable to comply with study visit schedule and timeline Past significant intracranial surgery A female lactating or of child-bearing potential, with a positive pregnancy test or not using adequate contraception.
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Bilateral subgenual cingulate deep brain stimulation (SGC DBS)
Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone. All patients will receive deep brain stimulation (DBS) targeting the subgenual cingulate (SGC) bilaterally. No other changes to pre-existing treatment will be made. This is the only arm in this experiment.