In neurological disease, current treatments that remove or reduce the causes at the cellular level or inhibit the onset or progression of disorders are often not sufficient on their own to regenerate neural function. Diseases in which such neural functional recovery is very challenging include stroke, spinal cord injury, encephalitis, multiple sclerosis, neurodegenerative diseases such as Parkinson's disease and related disorders, neuromuscular diseases such as spinal muscular atrophy, amyotrophic lateral sclerosis, and muscular dystrophy, and peripheral nerve diseases such as Guillain-Barre syndrome, familial amyloidotic polyneuropathy, and Charcot-Marie-Tooth disease.
Many aetiology-based treatments have been developed, but their effectiveness in regenerating neural function in clinical trials has been limited. This is extremely disappointing for patients and can result in discouraging research into developing new therapies. Furthermore, it may limit the potential for the development of an effective means of recovering function after the onset of the disease. Functional recovery must be the ultimate goal for treating nervous and neuromuscular systems. However, new and cutting-edge therapies such as enzymes, antibodies, nucleotides, gene transfer, small molecules and stem cells alone have thus far been shown to provide only partial functional recovery in neurological disorders.
Neuroprosthetic and Robotic devices are hugely promising therapeutic strategies in neurorehabilitation. They can have been shown to improve the gait function of patients with incurable, progressive neuromuscular diseases using cybernic devices. See for example https://doi.org/10.1186/s13023-021-01928-9. Furthermore, specific Research is needed on combined therapies with various devices such as robots, TMS, FES, BMI, EEG/NIRS-feedback, and Cybernic devices that can activate biofeedback loops and improve neural functions. However, at present, neither pilot trials, clinical trials, nor observational studies have been carried out.
This Research Topic aims to collect updated knowledge on how Device-supported Neuro-functional approaches can be integrated alongside classical treatments for neurodegeneration to improve patient outcomes and aid functional recovery. The editors welcome any types of manuscripts supported by the Journal – pertaining, but not limited to the following themes:
• Research reports not just on the device development itself but on the biological use of these devices for functional regeneration.
• Study reports on safety and efficacy in endpoints and on elucidating the mechanisms of functional regeneration with biomarkers; This can include case series, observational studies, and controlled trials (but see notes below). To stimulate this research area, we invite submissions of the results of these studies, including those in the preparatory stages.
• Studies on the efficacy and safety of Device-supported Neuro-functional approach with specific functional measures of recovery
• Pivotal RCTs mentioned above are welcome, as are pilot trials and case series studies aiming for RCTs.
We do not encourage the submission of single case reports unless there is clearly demonstrated a link between the underlying functional and biological recovery e.g., through the use of quantifiable biomarkers etc. see for example https://doi.org/10.3389/FNEUR.2022.905613. We also strongly encourage study reports on safety and efficacy in endpoints and on elucidating the mechanisms of functional regeneration with biomarkers. See for example https://www.jns-journal.com/article/S0022-510X(20)30276-8/fulltext and https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191361.
Prospects for future available methods of clinical neurorehabilitation based on results from neural science are welcome, as results from laboratory studies, provided they are modeled for clinical application. In addition, we encourage content that illustrates the potential of future combined therapies with drugs, regenerative medicine, and devices at the cellular, animal, and clinical levels, together with functional regeneration and its biomarkers.
Potential conflicts of interest: Dr Yoshiki Sekijima receives Honoraria as well as research grants from Pfizer and Alnylam Pharmaceuticals. Dr Eiichi Tsuda received financial support for medical research from private hospitals (Hirosaki Memorial Hospital, Seijinkai Ono Hospitao, Jijinkai Ono Hospital, Nishikawa Hand and Orthopaedic Clinic, Komatsu Orthopaedic Clinic, Mitsuka Orthopaedic Clinic, and Aomori Jikeikai Hospital). Additionally, Dr Susanne Palmcrantz receives financial support for research purpose from a company, and is an advisory board member of a private company
In neurological disease, current treatments that remove or reduce the causes at the cellular level or inhibit the onset or progression of disorders are often not sufficient on their own to regenerate neural function. Diseases in which such neural functional recovery is very challenging include stroke, spinal cord injury, encephalitis, multiple sclerosis, neurodegenerative diseases such as Parkinson's disease and related disorders, neuromuscular diseases such as spinal muscular atrophy, amyotrophic lateral sclerosis, and muscular dystrophy, and peripheral nerve diseases such as Guillain-Barre syndrome, familial amyloidotic polyneuropathy, and Charcot-Marie-Tooth disease.
Many aetiology-based treatments have been developed, but their effectiveness in regenerating neural function in clinical trials has been limited. This is extremely disappointing for patients and can result in discouraging research into developing new therapies. Furthermore, it may limit the potential for the development of an effective means of recovering function after the onset of the disease. Functional recovery must be the ultimate goal for treating nervous and neuromuscular systems. However, new and cutting-edge therapies such as enzymes, antibodies, nucleotides, gene transfer, small molecules and stem cells alone have thus far been shown to provide only partial functional recovery in neurological disorders.
Neuroprosthetic and Robotic devices are hugely promising therapeutic strategies in neurorehabilitation. They can have been shown to improve the gait function of patients with incurable, progressive neuromuscular diseases using cybernic devices. See for example https://doi.org/10.1186/s13023-021-01928-9. Furthermore, specific Research is needed on combined therapies with various devices such as robots, TMS, FES, BMI, EEG/NIRS-feedback, and Cybernic devices that can activate biofeedback loops and improve neural functions. However, at present, neither pilot trials, clinical trials, nor observational studies have been carried out.
This Research Topic aims to collect updated knowledge on how Device-supported Neuro-functional approaches can be integrated alongside classical treatments for neurodegeneration to improve patient outcomes and aid functional recovery. The editors welcome any types of manuscripts supported by the Journal – pertaining, but not limited to the following themes:
• Research reports not just on the device development itself but on the biological use of these devices for functional regeneration.
• Study reports on safety and efficacy in endpoints and on elucidating the mechanisms of functional regeneration with biomarkers; This can include case series, observational studies, and controlled trials (but see notes below). To stimulate this research area, we invite submissions of the results of these studies, including those in the preparatory stages.
• Studies on the efficacy and safety of Device-supported Neuro-functional approach with specific functional measures of recovery
• Pivotal RCTs mentioned above are welcome, as are pilot trials and case series studies aiming for RCTs.
We do not encourage the submission of single case reports unless there is clearly demonstrated a link between the underlying functional and biological recovery e.g., through the use of quantifiable biomarkers etc. see for example https://doi.org/10.3389/FNEUR.2022.905613. We also strongly encourage study reports on safety and efficacy in endpoints and on elucidating the mechanisms of functional regeneration with biomarkers. See for example https://www.jns-journal.com/article/S0022-510X(20)30276-8/fulltext and https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191361.
Prospects for future available methods of clinical neurorehabilitation based on results from neural science are welcome, as results from laboratory studies, provided they are modeled for clinical application. In addition, we encourage content that illustrates the potential of future combined therapies with drugs, regenerative medicine, and devices at the cellular, animal, and clinical levels, together with functional regeneration and its biomarkers.
Potential conflicts of interest: Dr Yoshiki Sekijima receives Honoraria as well as research grants from Pfizer and Alnylam Pharmaceuticals. Dr Eiichi Tsuda received financial support for medical research from private hospitals (Hirosaki Memorial Hospital, Seijinkai Ono Hospitao, Jijinkai Ono Hospital, Nishikawa Hand and Orthopaedic Clinic, Komatsu Orthopaedic Clinic, Mitsuka Orthopaedic Clinic, and Aomori Jikeikai Hospital). Additionally, Dr Susanne Palmcrantz receives financial support for research purpose from a company, and is an advisory board member of a private company
