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Published on: February 23, 2020
Why do some promising brain-stimulation devices fail the next steps of clinical development?
Rodrigo C L Edelmuth1, Michael A Nitsche, Linamara Battistella
1Laboratory of Neuromodulation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA.
Expert Review of Medical Devices
|December 22, 2009
Summary
Many noninvasive brain stimulation (NIBS) techniques show promise but fail to reach clinical practice. Reasons include poor result dissemination, lack of controlled studies, and standardization issues.
Area of Science:
- Neuroscience
- Neurology
- Biomedical Engineering
Background:
- Noninvasive brain stimulation (NIBS) techniques have gained significant interest due to their neurophysiological and clinical effects.
- Despite promising results, several NIBS methods have been abandoned before widespread clinical adoption.
Purpose of the Study:
- To systematically review NIBS methods with promising preliminary clinical results that were not fully developed.
- To identify reasons for the failure of these promising NIBS devices to reach clinical practice.
- To compare these devices with established NIBS methods and neuropsychiatric drugs.
Main Methods:
- Systematic review of NIBS techniques with promising preliminary clinical results.
- Identification and analysis of five under-developed NIBS devices.
- Comparison with established NIBS (TMS, tDCS) and pharmacological treatments (pramipexole, escitalopram).
- Discussion of novel NIBS devices like brain ultrasound and transcranial high-frequency random noise stimulation.
Main Results:
- Five under-developed NIBS devices were identified: transmeatal cochlear laser stimulation, transcranial micropolarization, transcranial electrostimulation, cranial electric stimulation, and weak electromagnetic field stimulation.
- Key barriers to clinical adoption include difficulty disseminating results, insufficient controlled studies, prolonged research duration, mixed findings, and lack of standardization.
- Novel techniques like brain ultrasound and transcranial high-frequency random noise stimulation show recent promise.
Conclusions:
- Promising NIBS technologies face significant hurdles in clinical translation.
- Addressing issues of standardization, robust study design, and result dissemination is crucial for future NIBS development.
- Further research and development are needed to overcome barriers and realize the full clinical potential of NIBS.
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