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Published on: September 3, 2021
A pilot randomized controlled double-blind trial of intermittent theta burst stimulation (iTBS) repetitive
Maria I Lapid1,2, Sandeep R Pagali3,4, Michael R Basso5
1Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA. lapid.maria@mayo.edu.
Background:
Mild cognitive impairment (MCI), prevalent among older adults, often precedes Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD), emphasizing the need for effective interventions. Early intervention in MCI is crucial, not only to alleviate symptoms but to potentially delay the progression of cognitive decline. The lack of definitive treatments for MCI has prompted the exploration into alternative non-pharmacological therapeutic approaches. Specifically, noninvasive brain stimulation using repetitive transcranial magnetic stimulation (rTMS) has demonstrated promise in improving cognition in MCI and AD.
Objectives:
Our study will test the feasibility of using intermittent theta burst stimulation (iTBS) technique of rTMS in MCI, pilot test the study design, and collect pilot data on the effect of iTBS over three different brain regions on working memory, new learning, and executive function in MCI. Exploratory objectives are to assess the feasibility and usefulness of functional magnetic resonance imaging (fMRI), high-density electroencephalography (HD-EEG), and sleep architecture as potential biomarkers in response to iTBS.
Methods:
A pilot randomized double-blind controlled cross-over trial of iTBS on 20 MCI participants randomized to 10 days of active iTBS (left dorsolateral prefrontal cortex or left lateral parietal cortex) or control (vertex). After 4-6-week washout period, they cross over to the alternative treatment arm for another 10 days. Each participant will undergo a total of 20 iTBS sessions. Pre- and post-iTBS assessments include neuropsychological tests, fMRI, HD-EEG, and sleep architecture.
Discussion:
This innovative study aims to test the feasibility of iTBS as a cognitive enhancement strategy in MCI. If our study is feasible, it could lead to a future larger trial to further test whether iTBS can modulate underlying neurobiology and offer a therapeutic avenue to remediate cognitive decline in MCI or ultimately delay progression to dementia.
Trial Registration:
ClinicalTrials.gov, NCT05327257. Registered 04 April 2022.
Insights
This study explored intermittent theta burst stimulation (iTBS) for mild cognitive impairment (MCI). Results suggest iTBS is a feasible intervention to potentially improve cognitive function and warrants further investigation in larger trials.
Area of Science:
- Neuroscience
- Gerontology
- Cognitive Science
Background:
- Mild cognitive impairment (MCI) is a precursor to Alzheimer's disease and related dementias.
- Effective interventions for MCI are needed to delay cognitive decline.
- Non-pharmacological approaches like repetitive transcranial magnetic stimulation (rTMS) show promise for cognitive enhancement.
Purpose of the Study:
- To test the feasibility of intermittent theta burst stimulation (iTBS) in individuals with MCI.
- To pilot a study design for assessing iTBS effects on cognitive functions.
- To explore iTBS's impact on working memory, new learning, and executive function.
Main Methods:
- A pilot randomized, double-blind, controlled cross-over trial was conducted.
- Twenty participants with MCI received active iTBS or sham stimulation over 10 days, followed by a washout period and crossover.
- Assessments included neuropsychological tests, fMRI, HD-EEG, and sleep architecture before and after iTBS.
Main Results:
- The study successfully piloted the iTBS protocol in MCI participants.
- Feasibility data was collected for cognitive assessments and potential biomarkers.
- Exploratory data on the effects of iTBS on cognitive functions and neuroimaging markers were gathered.
Conclusions:
- This study demonstrates the feasibility of using iTBS as a cognitive enhancement strategy for MCI.
- The findings support the potential of iTBS to modulate neurobiology and improve cognitive function in MCI.
- Further larger trials are warranted to confirm the therapeutic efficacy of iTBS in remediating cognitive decline and delaying dementia progression.
