Cognitive Effects of Theta-burst Stimulation (TBS) in Suspected Non-Alzheimer Disease Pathophysiology (SNAP)

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jun 27, 2022

Keywords

ClinConnect Summary

This is a small, upfront study to see if a non-invasive brain stimulation method called intermittent theta-burst stimulation (iTBS) can help people with a specific type of dementia called SNAP (suspected non-Alzheimer’s disease pathophysiology). In this randomized, controlled trial, 20 participants will receive iTBS to the left side of the brain’s frontal area five days a week for four weeks. The first two weeks compare real stimulation to a sham (placebo) setup, and then there’s an open-label period for the next two weeks where all participants may receive active stimulation. Researchers will measure thinking and memory using tests before treatment, right after two and four weeks of treatment, and again eight weeks after finishing the sessions. Brain scans using FDG-PET will also be done before and after treatment to explore possible brain changes.

To be eligible, people should be 50 to 90 years old and meet criteria for SNAP with a major neurocognitive disorder (dementia), and have had an amyloid-PET test already. They should have a Clinical Dementia Rating (CDR) of 0.5 to 2. Exclusion criteria include a history of epilepsy, major brain injuries, unstable serious medical conditions, substance abuse, pregnancy, and MRI or PET incompatibilities. The study is at Chang Gung Memorial Hospital in Taoyuan, Taiwan, and is currently enrolling by invitation with completion expected around the end of 2025. This pilot aims to identify a well-defined SNAP group for brain stimulation research and to understand potential brain mechanisms behind any observed effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects aged 50-90 year.
• • 2. Patients meet NIA-AA research criteria for suspected non-Alzheimer disease pathophysiology (SNAP) (Petersen, Smith et al. 1999; Jack, Bennett et al. 2018), and DSM-5 criteria for major neurocognitive disorder of dementia (Regier, Narrow et al. 2013).
• • 3. Amyloid PET should ever be performed.
• • 4. The CDR of subjects can be 0.5-2.
• Exclusion Criteria:
• • 1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
• • 2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. (cerebrovascular disorders, hydrocephalus and intra-cranial mass, documented by MRI; a history of traumatic brain injury or another neurological disease).
• • 3. Any subject has clinically significant or unstable medical diseases including metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
• • 4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia, bipolar disorder, and previously prolonged substances abuse.
• • 5. Any females who is pregnant or lactating.
• • 6. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.
• • Withdrawal criteria
• • 1. Complications onset after intervention that affect efficacy and safety judgments.
• • 2. New onset or progression of disease that may affect outcomes.
• • 3. Use of other therapies or drugs during the intervention period to change cognitive functions.
• • 4. Any subjects who are recognized as high risk of adverse effects by principle investigator.