Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury

Kletzel, Sandra; Aaronson, Alexandra; Guernon, Ann; Carbone, Christina; Chaudhry, Noor; Walsh, Elyse; Conneely, Mark; Patil, Vijaya; Roth, Elliott; Steiner, M; Pacheco, Marilyn; Rosenow, Joshua M.; Pape, Theresa

doi:10.1097/htr.0000000000000636

Cited by 12 publications

(6 citation statements)

References 20 publications

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“…Based on our observations, limited potential risks are associated with the combined intervention after TBI. These findings align with existing literature ( Bornstein et al, 2018 ; Kim and Paik, 2020 ; Kletzel et al, 2020 ; Strilciuc et al, 2021 ). Therefore, both Cerebrolysin and its neuromodulatory enhancement by rTMS should be considered as candidates when deciding a neurorehabilitation strategy for TBI in patients who have access to such interventions.…”

Section: Discussionsupporting

confidence: 92%

Cerebrolysin and repetitive transcranial magnetic stimulation (rTMS) in patients with traumatic brain injury: a three-arm randomized trial

et al. 2023

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IntroductionTraumatic brain injury (TBI) is a major public health problem affecting millions worldwide. Despite significant advances in medical care, there are limited effective interventions for improving cognitive and functional outcomes in TBI patients.MethodsThis randomized controlled trial investigated the safety and efficacy of combining repetitive transcranial magnetic stimulation (rTMS) and Cerebrolysin in improving cognitive and functional outcomes in TBI patients. Ninety-three patients with TBI were randomized to receive either Cerebrolysin and rTMS (CRB + rTMS), Cerebrolysin and sham stimulation (CRB + SHM), or placebo and sham stimulation (PLC + SHM). The primary outcome measures were the composite cognitive outcome scores at 3 and 6 months after TBI. Safety and tolerability were also assessed.ResultsThe study results demonstrated that the combined intervention of rTMS and Cerebrolysin was safe and well-tolerated by patients with TBI. Although no statistically significant differences were observed in the primary outcome measures, the descriptive trends in the study support existing literature on the efficacy and safety of rTMS and Cerebrolysin.DiscussionThe findings of this study suggest that rTMS and Cerebrolysin may be effective interventions for improving cognitive and functional outcomes in TBI patients. However, limitations of the study, such as the small sample size and exclusion of specific patient populations, should be considered when interpreting the results. This study provides preliminary evidence for the safety and potential efficacy of combining rTMS and Cerebrolysin in improving cognitive and functional outcomes in TBI patients. The study highlights the importance of multidisciplinary approaches in TBI rehabilitation and the potential for combining neuropsychological measurements and interventions to optimize patient outcomes.ConclusionFurther research is needed to establish these findings’ generalizability and identify the optimal dosages and treatment protocols for rTMS and Cerebrolysin.

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Section: Discussionsupporting

confidence: 92%

Cerebrolysin and repetitive transcranial magnetic stimulation (rTMS) in patients with traumatic brain injury: a three-arm randomized trial

et al. 2023

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“…Pape et al [ 41 ] also reported an electroencephalographic seizure without clinical accompaniment after the 21st excitatory rTMS session in a 32-year-old man with disordered consciousness after TBI. In an open-label study including seven patients with disordered consciousness after traumatic brain injuries, 75 nonserious adverse events and one seizure were reported during total 30 excitatory rTMS sessions (300 pulses/session) over the right or left dorsolateral prefrontal cortex [ 42 ]. One patient with a seizure event during the rTMS trial continued planned rTMS sessions with antiepileptic drugs and no seizure recurrence was observed.…”

Section: Safety Considerations In Stroke and Tbimentioning

confidence: 99%

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation

Kim

Paik

2021

Brain Neurorehabil

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Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.

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“…The most common adverse effects of rTMS are transient headaches, local discomfort in the targeted area, dizziness, and, very rarely, seizure [ 144 ]. It is important to screen for potential (subclinical) seizures in patients with DoC prior to rTMS treatment [ 145 ]. As with tES, the main limitations are the moderate and transient behavioral effects.…”

Section: Electromagnetic Therapiesmentioning

confidence: 99%

Therapies to Restore Consciousness in Patients with Severe Brain Injuries: A Gap Analysis and Future Directions

et al. 2021

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Background/Objective For patients with disorders of consciousness (DoC) and their families, the search for new therapies has been a source of hope and frustration. Almost all clinical trials in patients with DoC have been limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use; amantadine is the only therapy recommended by current clinical guidelines, specifically for patients with DoC caused by severe traumatic brain injury. To foster and advance development of consciousness-promoting therapies for patients with DoC, the Curing Coma Campaign convened a Coma Science Work Group to perform a gap analysis. Methods We consider five classes of therapies: (1) pharmacologic; (2) electromagnetic; (3) mechanical; (4) sensory; and (5) regenerative. For each class of therapy, we summarize the state of the science, identify gaps in knowledge, and suggest future directions for therapy development. Results Knowledge gaps in all five therapeutic classes can be attributed to the lack of: (1) a unifying conceptual framework for evaluating therapeutic mechanisms of action; (2) large-scale randomized controlled trials; and (3) pharmacodynamic biomarkers that measure subclinical therapeutic effects in early-phase trials. To address these gaps, we propose a precision medicine approach in which clinical trials selectively enroll patients based upon their physiological receptivity to targeted therapies, and therapeutic effects are measured by complementary behavioral, neuroimaging, and electrophysiologic endpoints. Conclusions This personalized approach can be realized through rigorous clinical trial design and international collaboration, both of which will be essential for advancing the development of new therapies and ultimately improving the lives of patients with DoC.

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Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury

Cited by 12 publications

References 20 publications

Cerebrolysin and repetitive transcranial magnetic stimulation (rTMS) in patients with traumatic brain injury: a three-arm randomized trial

Cerebrolysin and repetitive transcranial magnetic stimulation (rTMS) in patients with traumatic brain injury: a three-arm randomized trial

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation

Therapies to Restore Consciousness in Patients with Severe Brain Injuries: A Gap Analysis and Future Directions

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