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Randomized Controlled Trial
. 2024 Apr;21(3):e00331.
doi: 10.1016/j.neurot.2024.e00331. Epub 2024 Feb 14.

Repetitive transcranial magnetic stimulation as a treatment for Alzheimer's disease: A randomized placebo-controlled double-blind clinical trial

Zahra Moussavi  1 , Maria Uehara  2 , Grant Rutherford  2 , Brian Lithgow  3 , Colleen Millikin  4 , Xikui Wang  5 , Chandan Saha  2 , Behzad Mansouri  6 , Craig Omelan  7 , Lesley Fellows  8 , Paul B Fitzgerald  9 , Lisa Koski  10
Affiliations
Randomized Controlled Trial

Repetitive transcranial magnetic stimulation as a treatment for Alzheimer's disease: A randomized placebo-controlled double-blind clinical trial

Zahra Moussavi et al. Neurotherapeutics. 2024 Apr.

Erratum in

Abstract

We report results of a large multisite double-blind randomized trial investigating the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) applied to patients with Alzheimer's disease (AD) at mild to moderate stages, in doses of either 2 or 4 weeks of treatment (5 days/week), whilst compared with 4 weeks of sham rTMS. Randomization to treatment group was stratified based on age and severity. The objectives of this study were to: 1) investigate the efficacy of active rTMS versus sham, 2) investigate the effect of dose of treatment (2 or 4 weeks), and 3) investigate the length of benefits from treatment. The rTMS pulses (20 ​Hz, 30 pulses/train, 25 trains, 10-s intertrain interval) were applied serially to the left and right dorsolateral prefrontal cortex using neuro-navigation. We compared the primary outcome measure's (ADAS-Cog) score changes from pre- to post-treatment, with assessments at baseline and 4 more times up to 6 months post-treatment. Data of 135 patients were analyzed. The mean total ADAS-Cog score at baseline did not differ between the active and sham treatment groups, nor across the three study sites. The overall results show significant cognitive improvement after treatment up to two months post-treatment with either sham or active coils. The results show both short and long-term benefits of active rTMS treatment but also show similar benefits for sham coil treatment of mild/moderate AD. We discuss this finding in the context of the existing literature on rTMS therapy for AD, as well as evidence of the sham coil's potential to induce a low-level current in the brain. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02908815.

Keywords: Alzheimer's disease; Dorsolateral prefrontal cortex; Double-blind; Randomized clinical trial; rTMS efficacy.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Zahra Moussavi reports financial support was provided by Weston Brain Institute. Paul B Fitzgerald reports a relationship with National Health and Medical Research Council of Australia Investigator grant (1193596) that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flowchart of the study groups and number in each group and site.
Fig. 2
Fig. 2
Boxplot of the ADAS-Cog total score of participants at baseline and a given time point in different participant treatment groups.
Fig. 3
Fig. 3
Boxplot of the difference between the log(ADAS-Cog) of participants at baseline and a given time point in different participant treatment groups with their statistical comparisons.
Fig. 4
Fig. 4
Frequency of the different response types in each group of R2, R4 and S4 across all sites.
Fig. 5
Fig. 5
ADAS-Cog changes (μ ​± ​σ) with respect to baseline at assessment Weeks of 5, 12, 20 and 28 after the baseline for each group of the study across all sites. Negative and positive values imply improvement and decline, respectively (the lower ADAS-Cog, the better cognitive status).
See this image and copyright information in PMC

References

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