Deep TMS: A comprehensive summary of adverse events from five multicenter trials

Tendler, Aron; Gersner, Roman; Roth, Yiftach; Stein, Ahava; Harmelech, Tal; Hanlon, Colleen A.

doi:10.1016/j.brs.2023.07.048

Cited by 2 publications

(4 citation statements)

References 9 publications

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“…Furthermore, the double-blind, sham-controlled trial by Spagnolo et al (2020) demonstrated that active Deep TMS significantly improved outcomes on the UPDRS tremor subscale. From a safety perspective, AE rates were very low and consistent with the AE rates of the H4 Coil in previously published multisite randomized clinical trials ( Tendler et al, 2023 ). The efficacy of Deep TMS in PD is likely to be dependent on patient selection.…”

Section: Discussionsupporting

confidence: 85%

“…The dropout rate for Deep TMS in PD studies was low (only 4 out of 220 subjects dropped out across six studies). The H2 and H5 Coils are almost identical to the H4 Coil, which has the lowest rates of AEs in a recently published compilation of AEs from five multicenter Deep TMS studies ( Tendler et al, 2023 ).…”

Section: Summary Of the Studiesmentioning

confidence: 86%

“…All AEs were minor and transient in their duration. This included AEs which are commonly reported across TMS studies ( Tendler et al, 2023 ), such as headache and pain at the site of stimulation. Specifically, headaches, face pain and discomfort occurred in 16% of subjects.…”

Section: Summary Of the Studiesmentioning

confidence: 99%

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Bilateral deep transcranial magnetic stimulation of motor and prefrontal cortices in Parkinson’s disease: a comprehensive review

Hanlon,

Lench,

Pell

et al. 2024

Front. Hum. Neurosci.

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Parkinson’s disease (PD) is a prevalent neurodegenerative disorder characterized by both motor and non-motor symptoms, many of which are resistant to currently available treatments. Since the discovery that non-invasive transcranial magnetic stimulation (TMS) can cause dopamine release in PD patients, there has been growing interest in the use of TMS to fill existing gaps in the treatment continuum for PD. This review evaluates the safety and efficacy of a unique multifocal, bilateral Deep TMS protocol, which has been evaluated as a tool to address motor and non-motor symptoms of PD. Six published clinical trials have delivered a two-stage TMS protocol with an H-Coil targeting both the prefrontal cortex (PFC) and motor cortex (M1) bilaterally (220 PD patients in total; 108 from two randomized, sham-controlled studies; 112 from open label or registry studies). In all studies TMS was delivered to M1 bilaterally (Stage 1) and then to the PFC bilaterally (Stage 2) with approximately 900 pulses per stage. For Stage 1 (M1), two studies delivered 10 Hz at 90% motor threshold (MT) while four studies delivered 1 Hz at 110% MT. For Stage 2 (PFC), all studies delivered 10 Hz at 100% MT. The results suggest that this two-stage Deep TMS protocol is a safe, moderately effective treatment for motor symptoms of PD, and that severely impaired patients have the highest benefits. Deep TMS also improves mood symptoms and cognitive function in these patients. Further research is needed to establish optimal dosing and the long-term durability of treatment effects.

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Section: Discussionsupporting

confidence: 85%

Section: Summary Of the Studiesmentioning

confidence: 86%

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Bilateral deep transcranial magnetic stimulation of motor and prefrontal cortices in Parkinson’s disease: a comprehensive review

Hanlon,

Lench,

Pell

et al. 2024

Front. Hum. Neurosci.

Self Cite

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“…The most serious adverse event reported is seizures, which are very rare and occur at a frequency of less than 0.001 [39]. The most common adverse events of Deep TMS are headache, treatment site discomfort and facial muscle pain [40]. Most of the adverse events are transient, are resolved within days, and their severity is mild to moderate.…”

Section: Discussionmentioning

confidence: 99%

Never Too Late: Safety and Efficacy of Deep TMS for Late-Life Depression

Roth,

Munasifi,

Harvey

et al. 2024

JCM

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Repetitive transcranial magnetic stimulation (rTMS) is an effective and well-established treatment for major depressive disorder (MDD). Deep TMS utilizes specially designed H-Coils to stimulate the deep and broad cerebral regions associated with the reward system. The improved depth penetration of Deep TMS may be particularly important in late-life patients who often experience brain atrophy. The aim of this phase IV open-label study was to evaluate the safety and efficacy of Deep TMS in patients with late-life MDD. Data were collected from 247 patients with MDD aged 60–91 at 16 sites who had received at least 20 Deep TMS sessions for MDD. The outcome measures included self-assessment questionnaires (Patient Health Questionnaire-9 (PHQ-9), Beck Depression Inventory-II (BDI-II)) and clinician-based scales (21-item Hamilton Depression Rating Scale (HDRS-21)). Following 30 sessions of Deep TMS, there was a 79.4% response and 60.3% remission rate on the most rated scale. The outcomes on the PHQ-9 were similar (76.6% response and 54.7% remission rate). The highest remission and response rates were observed with the HDRS physician-rated scale after 30 sessions (89% response and a 78% remission rate). After 20 sessions, there was a 73% response and 73% remission rate on the HDRS. Consistent with prior studies, the median onset of response was 14 sessions (20 days). The median onset of remission was 15 sessions (23 days). The treatment was well tolerated, with no reported serious adverse events. These high response and remission rates in patients with treatment-resistant late-life depression suggest that Deep TMS is a safe, well-tolerated and effective treatment for this expanded age range of older adults.

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Deep TMS: A comprehensive summary of adverse events from five multicenter trials

Cited by 2 publications

References 9 publications

Bilateral deep transcranial magnetic stimulation of motor and prefrontal cortices in Parkinson’s disease: a comprehensive review

Bilateral deep transcranial magnetic stimulation of motor and prefrontal cortices in Parkinson’s disease: a comprehensive review

Never Too Late: Safety and Efficacy of Deep TMS for Late-Life Depression

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