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The Effects of Intermittent Theta Burst Stimulation in MCI and Early AD

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04555941
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9.8
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique that is increasingly used for a growing number of research and clinical applications.Typically, this transient magnetic field is focally applied with a figure-of-eight coil that is carefully placed on the surface of the scalp over a targeted stimulation site. Patterned repetitive TMS (rTMS), such as theta burst stimulation (TBS) can produce long-lasting effects on neural activity and behavior beyond the stimulation period (Chou et al., 2015a; Fitzgerald et al., 2006). In general, high frequency (> 5 Hz) rTMS and its newer version, intermittent theta burst stimulation (iTBS), facilitate cortical excitability, whereas low frequency (about 1 Hz) rTMS and continuous theta burst stimulation contribute to opposite effects (Pascual-Leone et al., 2000; Huang et al., 2005; Wassermann and Zimmermann, 2012).Careful manipulation of the parameters comprising these patterned rTMS pulse trains can induce neuroplastic changes that resemble either long-term potentiation (LTP) or depression (Chen et al., 1997; Pascual-Leone et al., 1994). Early studies targeting the motor cortex helped elucidate which rTMS parameters promote particular responses and their neurophysiological underpinnings (Klomjai et al., 2015).

In recent years, rTMS has been closely investigated to evaluate its potential to modulate cognitive functions in Alzheimer'sdisease (AD) and mild cognitive impairment (MCI). As compared to conventional excitatory rTMS protocols, iTBS leads to comparable effects with similar number of pulses but considerable shorter duration and lower intensity of stimulation (Bakker et al., 2015; Rossi, Hallett, Rossini, Pascual-Leone, & Safety, 2009). Recent literature also suggest that TBS has lower rates of reported adverse event (AE) compared to rTMS (Najib & Horvath, 2014). Therefore, iTBS is assumed to modulate cognitive function in people with cognitive impairments.

Condition or Disease Intervention/Treatment Phase
  • Device: intermittent theta burst stimulation
 Phase 2

Detailed Description

Visit 1: Informed Consent, Brain MRI/Neuropsychological Battery

Visit 2-11: (up to a week after visit 1) iTBS - or Sham-Treatment (10 sessions, 80% Resting Motor Threshold, 2s stimulation 8s inter-stimulus interval per train, 20 trains per block, 3 blocks per session with a 5-min break, 1 session per day)

Visit 12: (1 day or same day after visit 11) Functional Brain MRI/Neuropsychological Battery

Visit 13: (4 weeks after visit 11) Functional Brain MRI/Neuropsychological Battery

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The participant and principal investigator do not know what treatment is applied. The outcomes assessor will also be blinded. Only the co-PI who perform the TMS will know the stimulation condition.
Primary Purpose:
Treatment
Official Title:
Cognitive Effects of Theta Burst Stimulation in Mild Cognitive Impairment and Alzheimer's Disease
Actual Study Start Date :
Oct 5, 2020
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: active iTBS

The patient is treated with iTBS stimulation according to protocol with an active coil.

Device: intermittent theta burst stimulation
active or Sham iTBS will be given to the AD/MCI patient
Other Names:
  • Magstim rapid 2

    		•
    Sham Comparator: Sham iTBS

    The patient is treated with Sham-iTBS stimulation according to protocol with an inactive coil.

    Device: intermittent theta burst stimulation
    active or Sham iTBS will be given to the AD/MCI patient
    Other Names:
  • Magstim rapid 2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from baseline in scores of any tests of the Neuropsychological Battery [Baseline, immediate post-iTBS, follow-up (4 weeks post-iTBS)]

      WAIS-IV short-form, Word Sequence Learning Test, Benton Visual Retention Test, Color Trial Tests, 3-D Dimensional Constructional Test, Visual Confrontation Naming, Semantic Verbal Fluency Test, Stroop Color-Word Test

    Secondary Outcome Measures

    1. Brain MRI [Baseline, immediate post-iTBS, follow-up (4 weeks post-iTBS)]

      Change in white matter and brain activities at resting state at baseline compared to after iTBS stimulation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • normal visual acuity

    • diagnosed with mild cognitive impairment or early dementia due to Alzheimer's disease (CDR = 0.5) by neurologists

    Exclusion Criteria:

    • (family) history of seizure attacks

    • in intensive care

    • history of drug/alcohol dependence

    • assistants or students of the PI

    • major systemic diseases concerning cognitive decline (e.g., cardiopulmonary failure, liver/renal failure, poor controlled DM, traumatic brain injury, stroke, or other neurodegenerative diseases)

    • claustrophobia

    • metal implants

    • taking medication lowering the threshold of seizure attacks

    • fear of using TMS

    • with specific allergens

    • pregnant or breastfeeding women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shuang Ho Hospital New Taipei City Taiwan

    Sponsors and Collaborators

    • Taipei Medical University Shuang Ho Hospital

    Investigators

    • Principal Investigator: Yi-Chun Kuan, MD, Taipei Medical University Shuang Ho Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheng-Chang Yang, Medical researcher, Taipei Medical University Shuang Ho Hospital
    ClinicalTrials.gov Identifier:
    NCT04555941
    Other Study ID Numbers:
    • N202003022
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cheng-Chang Yang, Medical researcher, Taipei Medical University Shuang Ho Hospital
    Transcranial magnetic stimulation
    non-invasive brain stimulation
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Oct 8, 2020