ITBS in MCI and Mild AD

NCT ID: NCT06670820

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2028-12-31

Brief Summary

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This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI) Mild Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active iTBS for Patients With MCI or AD

The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times.

Group Type ACTIVE_COMPARATOR

Active rTMS

Intervention Type DEVICE

iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions

Sham iTBS for Patients With MCI or AD

Sham stimulation will be delivered 10 sessions.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type DEVICE

sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions

Interventions

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Active rTMS

iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions

Intervention Type DEVICE

Sham rTMS

sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)
* Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)

Exclusion Criteria

* History of stroke
* History of uncontrol seizure
* History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality
* Mental illness
* Drug abuse
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Yu-Kai Lin

Tri-Service General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tri-Service General Hospital

Taipei, Other, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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YU-KAI LIN

Role: CONTACT

886-987-859-907

Facility Contacts

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Yu-Kai Lin

Role: primary

886-2-87923311 ext 10552,13907

Role: backup

886-987-859-907

References

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Daskalakis ZJ. Theta-burst transcranial magnetic stimulation in depression: when less may be more. Brain. 2014 Jul;137(Pt 7):1860-2. doi: 10.1093/brain/awu123. Epub 2014 May 15. No abstract available.

Reference Type BACKGROUND
PMID: 24833712 (View on PubMed)

Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

Reference Type BACKGROUND
PMID: 15664172 (View on PubMed)

Related Links

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Other Identifiers

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A202305164

Identifier Type: -

Identifier Source: org_study_id

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