A protocol for a multicenter randomized and personalized controlled trial using rTMS in patients with disorders of consciousness

Vitello, Marie M.; Rosenfelder, Martin; Cardone, Paolo; Niimi, Masachika; Willacker, Lina; Thibaut, Aurore; Laureys, Steven; Bender, Andreas; Gosseries, Olivia

doi:10.3389/fneur.2023.1216468

Cited by 4 publications

(1 citation statement)

References 62 publications

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“…Such theoretical and empirical frameworks provide a basis for understanding how SCS might contribute to the restoration of awareness in patients with disorders of consciousness, offering hope for augmenting their responsive states. Currently, non-surgical treatments include drug treatments such as amantadine, levodopa, baclofen, and zolpidem, as well as treatments including hyperbaric oxygen therapy, repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), midline nerve stimulation (MNS), and transcutaneous vagus nerve stimulation (taVNS) ( Gosseries et al, 2014 ; Edlow et al, 2021 ; Ruhl et al, 2022 ; Somaa et al, 2022 ; Vitello et al, 2023 ; Marino, 2024 ). It is also pertinent to consider the emerging evidence surrounding invasive neuromodulation techniques, notably deep brain stimulation (DBS).…”

Section: Discussionmentioning

confidence: 99%

Anatomical-related factors and outcome of percutaneous short-term spinal cord stimulation electrode shift in patients with disorders of consciousness: a retrospective study

He,

Yang,

et al. 2024

Front. Aging Neurosci.

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BackgroundDisorders of consciousness (DoC) represent a spectrum of neurological conditions that pose significant treatment challenges. Percutaneous short-term spinal cord stimulation (SCS) has emerged as a promising experimental diagnostic treatment to assess and potentially improve consciousness levels. However, the effectiveness of this intervention is frequently compromised by the shift of electrodes, particularly in the cervical region, which can negatively affect therapeutic outcomes.MethodsThis retrospective study aimed to study if electrodes shift in percutaneous short-term SCS in patients with DoC would affect the outcome. We analyzed the relationship between electrode shift length and patient outcome, as well as the correlation with various anatomical parameters, including the actual length of the cervical spine, linear length, spinal canal transverse diameter, spinal canal diameter, and C2 cone height, in a cohort of patients undergoing the procedure.ResultsOur findings revealed that in patients with better outcome, there are significant less patient with electrode shift (p = 0.019). Further, a linear correlation was found between the length of electrode shift and patients’ outcome (Rho = 0.583, p = 0.002), with longer shift lengths associated with poorer outcomes. Contrary to our expectations, there was no significant association between the measured anatomical parameters and the extent of electrode shift. However, a trend was found between the actual length of the cervical spine and the shift of the electrode (p = 0.098). Notably, the shorter spinal canal transverse diameter was found to be significantly associated with better outcome in patients with DoC receiving percutaneous short-term SCS (p = 0.033).ConclusionThese results highlight the clinical importance of electrode stability in the cervical region during SCS treatment for patients with DoC. Ensuring secure placement of electrodes may play a crucial role in enhancing patients’ outcome and minimize postoperative complications. Given the lack of association with expected anatomical parameters, future research should investigate other factors that could impact electrode stability to optimize this therapeutic intervention.

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Section: Discussionmentioning

confidence: 99%

Anatomical-related factors and outcome of percutaneous short-term spinal cord stimulation electrode shift in patients with disorders of consciousness: a retrospective study

He,

Yang,

et al. 2024

Front. Aging Neurosci.

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Brain health

Bonhomme,

Putensen,

Böttiger

et al. 2024

European Journal of Anaesthesiology Intensive Care

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Damage to the brain can have disastrous and long-lasting consequences. The European Society of Anaesthesiology and Intensive Care (ESAIC) is aware of the importance of taking good care of the brain, both of patients and of anaesthesia and intensive care unit (ICU) caregivers, and has organised a complete learning track on brain health to bring this concern to the attention of practitioners. This learning track included an online Focus Meeting on Brain Health (November 25, 2023). We here provide readers with a digest of the information that was delivered during that meeting in an opinion paper driven by the authors’ own reading of the literature. It is divided according to the meeting's sessions, including how to improve the health of an injured brain, how to keep a young or old brain healthy, how to keep a healthy adult brain unimpaired, how monitoring can impact brain health in the operating room and in the intensive care unit, and how to keep the anaesthesia and ICU caregivers’ brain healthy. Each part is a brief and focused summary. The main delivered messages are that the management of injured brain patients involves an adequate choice of sedation, adequate brain monitoring, and focused attention to specific points depending on the underlying pathology; that several measures can be undertaken to protect the brain of the very young needing anaesthesia; that it is possible to detect older patients at risk of postoperative neurocognitive disorders, and that dedicated perioperative management by a multidisciplinary expert team may improve their outcomes; that apparently healthy adult brains may suffer during anaesthesia; that the electroencephalogram may track peri-operative brain dysfunction, and that female patients should be given special care in this respect; that multimodal brain monitoring helps to detect pathological processes and to maintain brain homeostasis; and that burnout in anaesthesiologists can be effectively fought using personal, organisational, managerial and legal approaches.

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Perturbational complexity index in assessing responsiveness to rTMS treatment in patients with disorders of consciousness: a cross-over randomized controlled trial study

Xu,

Yuan,

Chen

et al. 2024

J NeuroEngineering Rehabil

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Background Disorders of Consciousness (DoC) caused by severe brain injuries represent a challenging clinical entity, which is easy to misdiagnosis and lacks effective treatment options. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuroelectric stimulation method that shows promise in improving consciousness for DoC, especially in minimally conscious state (MCS). However, there is little evidence of its effectiveness, especially in RCT studies. Methods Twenty MCS patients participated in a double-blind, randomized, crossover, sham-controlled clinical study to evaluate the safety and efficacy of rTMS for MCS. Subjects were randomized into two groups: one group received rTMS-active for 10 consecutive days ( n = 10), and the other group received rTMS-sham for 10 consecutive days ( n = 10). After a 10-day washout period, the two groups were crossed over and received the opposite treatment. the rTMS protocol consisted of 2,000 pulses per day in the left dorsolateral prefrontal cortex (L-DLPFC), sent at 10 Hz. The stimulation intensity was 90% of the resting motor threshold. Coma Recovery Scale Revised (CRS-R), the main evaluation index, was evaluated before and after each phase in a double-blind manner. Meanwhile RS-EEG and TMS-EEG data were acquired and relative alpha power (RAP), and perturbational complexity index based on state transitions (PCIst) were caculated. Results One-way ANOVA revealed significantly higher scores in rTMS-active treatment compared to rTMS-sham across various measures, including CRS-R total score, RAP, PCIst (all P < 0.05). Among the 20 MCS patients, 7 (35%) were identified as responders following rTMS treatment. Compared to rTMS-sham, responder scores for CRS-R, RAP, and PCIst (all P < 0.05) were significantly elevated after rTMS-active treatment. Conversely, there was no significant difference observed in non-responders. Furthermore, post-hoc analysis revealed that baseline PCIst was significantly higher in responders than non-responders. Upon a 6-month follow-up, CRS-R scores significantly increased in all 20 patients ( P = 0.026). However, the responder group exhibited a more favorable prognosis compared to the non-responder group ( P = 0.031). Conclusions Applying 10 Hz rTMS to L-DLPFC significantly increased consciousness level in MCS patients. PCIst is a neurophysiological index that has the potential to evaluate and predict therapeutic efficacy. Trial registration www.ClinicalTrials.gov , identifier: NCT05187000.

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A protocol for a multicenter randomized and personalized controlled trial using rTMS in patients with disorders of consciousness

Cited by 4 publications

References 62 publications

Anatomical-related factors and outcome of percutaneous short-term spinal cord stimulation electrode shift in patients with disorders of consciousness: a retrospective study

Anatomical-related factors and outcome of percutaneous short-term spinal cord stimulation electrode shift in patients with disorders of consciousness: a retrospective study

Brain health

Perturbational complexity index in assessing responsiveness to rTMS treatment in patients with disorders of consciousness: a cross-over randomized controlled trial study

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