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

NCT05440110 | Completed

• 1 other identifier: 202200400A0
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to identify a homogeneous cohort of pathologically specific dementia with SNAP for clinical trial of brain stimulation.

Conditions

Suspected Non-Alzheimer Disease Pathophysiology (SNAP)

Keywords

Suspected Non-Alzheimer Disease Pathophysiology (SNAP); theta-burst stimulation; repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcomes (2)

• The changes of Mini-Mental State Examination (MMSE) total scores

  The changes of Mini-Mental State Examination (MMSE) total scores (score range from 0 to 30, higher values represent a better cognitive outcome)

  baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4), and 8-week follow-up after TBS (T12)

• The changes of Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) total scores

  The changes of Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) total scores (score range from 0 to 70, higher score indicates a worse cognitive outcome)

  baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4), and 8-week follow-up after TBS (T12)

Secondary Outcomes (1)

• The standard uptake values changes of FDG-PET

  baseline (T0) and immediately after 2 weeks of TBS (T2), and 4 weeks of TBS (T4)

Study Arms (2)

active and active

ACTIVE COMPARATOR

The patients will be subjected to TBS for 5 daily interventions per week for four consecutive weeks.

Device: active and active TBS

sham and active

SHAM COMPARATOR

The patients will be subjected to TBS for 5 daily interventions per week for the first two weeks, followed by an open-label trial for the next two weeks.

Device: sham and active TBS

Interventions

active and active TBS DEVICE

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50- Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

active and active

sham and active TBS DEVICE

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50- Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min. Sham stimulation applies the same iTBS protocol with the sham coil.

sham and active

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Guishan, 333, Taiwan

Location

Study Officials

• KUAN YI WU

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized controlled clinical trial for the first two weeks, followed by an open-label trial for the next two weeks, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 20 SNAP dementia patients will be recruited for consecutive two years, and be subjected to iTBS for 5 daily interventions per week for four consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: October 18, 2022
• Primary Completion: August 15, 2025
• Study Completion: November 30, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

TW (1)