Status:
ENROLLING_BY_INVITATION
Cognitive Effects of Theta-burst Stimulation (TBS) in Suspected Non-Alzheimer Disease Pathophysiology (SNAP)
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Suspected Non-Alzheimer Disease Pathophysiology (SNAP)
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
This is a pilot study to identify a homogeneous cohort of pathologically specific dementia with SNAP for clinical trial of brain stimulation.
Detailed Description
The investigators apply the NIA-AA criteria to identify the individuals of biomarker-defined SNAP endophenotype. This is a prospective, randomized controlled clinical trial for the first two weeks, fo...
Eligibility Criteria
Inclusion
- Subjects aged 50-90 year.
- 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).
- Amyloid PET should ever be performed.
- The CDR of subjects can be 0.5-2.
Exclusion
- Any subject has a definite diagnosis of epilepsy or history of seizure attack.
- 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).
- 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.
- 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.
- Any females who is pregnant or lactating.
- 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
- Complications onset after intervention that affect efficacy and safety judgments.
- New onset or progression of disease that may affect outcomes.
- Use of other therapies or drugs during the intervention period to change cognitive functions.
- Any subjects who are recognized as high risk of adverse effects by principle investigator.
Key Trial Info
Start Date :
October 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05440110
Start Date
October 18 2022
End Date
December 31 2025
Last Update
February 14 2025
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Guishan, Taiwan, 333